Boston Scientific accounts are for healthcare professionals only.
Brief Summary Document - HCP
Product
Amplatz Super Stiff™ Guidewire - IFU number 51995436-01
Rx Statement
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. This device is restricted to use by or under the supervision of physicians trained in endoscopic urological biopsy procedures.
Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
Intended Use/Indications for Use
The Amplatz Super Stiff Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures. These guidewires are not intended for coronary artery, vascular or neurological use.
Contraindications
There are no known contraindications associated with the use of this product.
Warnings
- Failure to abide by the following warnings might result in damage to the channel or duct, abrasion of the PTFE coating, release of PTFE coating fragments from the guidewire, damage to or
- breakage/separation of the guidewire, that may necessitate intervention.
- Use caution if using with a metal needle or cannula. If the guidewire is being used with a metal cannula or needle and the guidewire needs to be withdrawn, remove the guidewire and metal cannula/needle as a unit, to reduce potential damage to the guidewire. If a needle is used for initial placement, a plastic entry needle is recommended when using the guidewire. Extreme caution should be observed when used with a one wall puncture style needle.
- Do not reshape the guidewire by any means. Attempting to reshape the guidewire may cause damage, resulting in the release of guidewire fragments to the urinary system.
- A retrieving device, such as a gripper or basket forceps, should only be used after the guidewire has been removed from the patient’s channel or duct. Using a retrieving device while the guidewire is in place may cause the guidewire to break.
Precautions
- When using a drug or a device concurrently with a guidewire, the operator should have a full understanding of the properties/ characteristics of the drug or device so as to avoid damage to the guidewire.
- When reinserting the guidewire back into the holder, take care not to damage the guidewire’s coating with the edge of the holder.\
- Do not use a metal torque device with the guidewire. Use of a metal torque device may result in damage to the guidewire. Also, do not slip a tightened up torque device over the guidewire, as this may result in damage to the guidewire.
Refer to Instructions for Use for all applicable information on Precautions.
Potential adverse events
Complications which can result from the use of guidewires in urological applications include:
- Allergic Reaction
- Avulsion
- Discomfort
- Edema
- Hematoma
- Hemorrhage
- Infection
- Fever
- Sepsis
- Urinary Tract Infection
- Inflammation
- Laceration
- Obstruction
- Pain
- Perforation
- Tissue Damage
- Unretrieved Device Fragment
Adverse events may require additional medical or surgical intervention.