Excelsior® SL-10 Microcatheter Straight Prescriptive Information
See package insert for complete indications, contraindications, warnings and instructions for use. IFUE90103980
INDICATIONS FOR USE
Boston Scientific’s reinforced Microcatheters are indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils into the peripheral, coronary and neurovasculature.
CONTRAINDICATIONS
None known.
POTENTIAL ADVERSE EFFECTS
Potential complications include, but are not limited to: infection, hematoma at the site of entry, vessel perforation, emboli, hemorrhage, ischemia, vasospasm, and neurological deficits including stroke and death. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.
CAUTIONS/PRECAUTIONS
- Federal law (USA) restricts this device to sale by or on the order of a physician.
- To reduce the probability of coating damage in tortuous vasculature, wide lumen guiding catheters are recommended for use with Boston Scientific hydrophilically coated microcatheters.
- In order to achieve optimal performance of Boston Scientific’s Microcatheters and to maintain the lubricity of the Hydrolene® Coating surface, it is critical that a continuous flow of appropriate flush solution be maintained between the Boston Scientific Microcatheter and guiding catheter and the microcatheter and any intraluminal device. In addition, flushing aids in preventing contrast crystal formation and/or clotting on both the intraluminal device and inside the guiding catheter and/or the microcatheter lumen.
- Do not position microcatheter closer than 2.54cm (1 in) from the steam source. Damage to the catheter may result.
- To control the proper introduction, movement, positioning and removal of the catheter within the vascular system, users should employ standard clinical angiographic and fluoroscopic practices and techniques throughout the interventional procedure.
- Flush dispenser coil of hydrophilically coated microcatheters prior to removal from dispenser coil. Once microcatheter has been wetted, do not allow to dry. Do not reinsert product into dispenser coil.
- Check that all fittings are secure so that air is not introduced into guiding catheter or microcatheter during continuous flush.
- Store in a cool, dry, dark place.
WARNINGS
- These devices are intended for use only by physicians trained in performing endovascular procedures.
- The Shaping Mandrel and accessories are not intended for use inside the human body.
- Carefully inspect all devices prior to use to verify the size, shape, and condition are suitable for the specific procedure.
- Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
- For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may: compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death; and create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
- Limited testing has been performed with solutions such as contrast media, saline and suspended embolic particles. The use of these catheters for the delivery of solutions other than the types that have been tested for compatibility is not recommended. Do not use with glue or glue mixtures.
- Do not use a microcatheter that has been damaged in any way. Damaged microcatheters may rupture, causing vessel trauma or tip detachment during steering maneuvers.
- Exchange microcatheters frequently during lengthy procedures that require extensive guidewire manipulation or multiple guidewire exchanges.
- Never advance or withdraw an intraluminal device against resistance. Movement of microcatheter or guidewire against resistance could dislodge a clot, perforate a vessel wall, or damage microcatheter and guidewire. In severe cases, tip separation of microcatheter or guidewire may occur.
- Do not exceed 2,070kPa (300 psi) infusion pressure. Excessive pressure could dislodge a clot causing thromboemboli, or could result in a ruptured microcatheter or severed tip causing vessel injury.
- Discontinue use of microcatheter for infusion if increased resistance is noted. Resistance indicates possible blockage. Remove and replace blocked microcatheter immediately. DO NOT attempt to clear blockage by over-pressurization. Doing so may cause the microcatheter to rupture, resulting in vascular damage or patient injury.
Excelsior® SL-10 Microcatheter Pre-Shaped Prescriptive Information
See package insert for complete indications, contraindications, warnings and instructions for use. IFUE 90143668.
INDICATIONS FOR USE
Boston Scientific’s Excelsior® SL-10 Pre-Shaped Microcatheter and Excelsior® 1018® Pre-Shaped Microcatheter are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils into the peripheral, coronary and neurovasculature.
CONTRAINDICATIONS
None known.
POTENTIAL ADVERSE EFFECTS
Potential complications include, but are not limited to: Death; Distal emboli (air, foreign material, tissue or thrombus); Drug reactions due to antiplatelet agents and/or contrast media; Hematoma; Hemorrhage; Infection; Ischemia; Pain at insertion site; Neurological deficits; Vessel spasm, dissection, perforation, rupture or injury. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.
WARNINGS
- These devices are intended for use only by physicians trained in performing endovascular procedures.
- Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
- For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
- The accessories are not intended for use inside the human body.
- Do not use if sterile packaging has been breached or damaged in any way.
- Do not use a microcatheter that has been damaged. Damaged microcatheters may rupture causing vessel trauma or tip detachment during steering maneuvers.
- Carefully inspect all devices prior to use. Verify shape, size and condition are suitable for the specific procedure.
- Microcatheter advancement beyond the end of the guidewire may result in vessel trauma.
- Exchange microcatheters frequently during lengthy procedures that require extensive guidewire manipulation or multiple guidewire exchanges.
- Never advance or withdraw an intraluminal device against resistance. Movement of the microcatheter or guidewire against resistance could dislodge a clot, perforate a vessel wall, or damage the microcatheter and guidewire. In severe cases, tip separation of microcatheter or guidewire may occur.
- Do not exceed maximum infusion pressure indicated for each microcatheter family. Excessive pressure may result in a ruptured microcatheter or severed tip. Boston Scientific
- Discontinue use of the microcatheter for infusion if increased resistance is noted. Resistance indicates possible blockage. Remove and replace the blocked microcatheter immediately. DO NOT attempt to clear blockage by over-pressurization. Doing so may cause the microcatheter to rupture, resulting in vascular damage or patient injury.
- Shaping mandrel is not intended for use inside the human body.
CAUTIONS/PRECAUTIONS
- Federal Law (USA) restricts this device to sale by or on the order of a physician.
- To reduce the probability of hydrophilic coating damage in tortuous vasculature, wide lumen guide catheters are recommended for use with Boston Scientific’s Pre-Shaped Microcatheters.
- To control the proper introduction, movement, positioning and removal of the microcatheter within the vascular system, users should employ standard clinical angiographic and fluoroscopic practices and techniques throughout the interventional procedure.
- Once the microcatheter has been wetted, do not allow to dry.
- The packaging mandrel is not intended for reuse. The packaging mandrel is not intended for use inside the human body.
- Check that all fittings are secure so that air is not introduced into the guide catheter or microcatheter during continuous flush.
- In order to achieve optimal performance of Boston Scientific’s Pre-Shaped Microcatheters and to maintain the lubricity of the hydrophilic surface, it is critical that a continuous flow of appropriate flush solution be maintained.
- Do not position Pre-Shaped Microcatheter closer than 1 inch (2,54 cm) from the steam source. Damage to the Pre-Shaped microcatheter may result.
