Prescriptive Information
Untitled Document
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Indications
This device is indicated to facilitate the placement of devices during diagnostic and interventional procedures.
Contraindications
There are no known Contraindications.
Warnings
Failure to abide by the following warnings might result in damage to the vessel, shearing of the ZIPwire Hydrophilic Guide Wire and release of plastic fragments from the ZIPwire Hydrophilic Guide Wire. Such pieces or fragments from the ZIPwire Hydrophilic Guide Wire may have to be removed from the vessel.
- The ZIPwire Hydrophilic Guide Wire may slide entirely into the catheter, sheath introducer, vessel dilator or other device because of its low sliding friction. To prevent this, keep at least 5cm of the ZIPwire Hydrophilic Guide Wire protruding from the device fitting at all times.
- When using a guide wire, potential exists for thrombus formation or emboli, arterial or venous wall damage and/or plaque dislodgment. The physician should be familiar with the literature concerning the complications of angiography.
- Do not manipulate or withdraw the ZIPwire Hydrophilic Guide Wire through a metal entry needle or a metal dilator. Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating, requiring retrieval. A plastic entry needle is recommended when using this wire for initial placement.
- Do not use the ZIPwire Hydrophilic Guide Wire with devices that contain metal parts such as atherectomy catheters, laser catheters, or metal introduction devices, as they may cause the ZIPwire Hydrophilic Guide Wire plastic coating to shear and/or sever the wire.
- Do not manipulate the ZIPwire Hydrophilic Guide Wire through a tightened rotating hemostasis valve, as this may result in damage to the wire.
- Do not reshape the ZIPwire Hydrophilic Guide Wire by any means. Attempting to reshape the wire may cause damage, resulting in the release of wire fragments into the vessel.
- When exchanging or withdrawing a catheter over the ZIPwire Hydrophilic Guide Wire, secure and maintain the guide wire in place under fluoroscopy to avoid unexpected guide wire advancement: otherwise, damage to the vessel wall by the wire’s tip may occur.
- A retrieving device, such as a gripper or basket forceps, can only be used after the ZIPwire Hydrophilic Guide Wire has been removed from the patient’s vessel. Using a retrieval device while the ZIPwire Hydrophilic Guide Wire is in the vessel may cause the ZIPwire Hydrophilic Guide Wire to break.
- When using a drug or a device concurrently with the ZIPwire Hydrophilic Guide Wire, the operator should have a full understanding of the properties/characteristics of the drug or device so as to avoid damage to the ZIPwire Hydrophilic Guide Wire.
- Do not attempt to use the ZIPwire Hydrophilic Guide Wire if it has been bent, kinked or damaged. Use of a damaged wire may result in damage to the vessel or the release of wire fragments into the vessel.
- Contents are supplied STERILE using an ethylene oxide (EO) process.
- Do not use if sterile barrier is damaged. Prior to use, inspect for damage. If damage is found, DO NOT USE and 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.
- Avoid manipulating or withdrawing the ZIPwire Hydrophilic Guide Wire back through a metal needle or cannula. A sharp edge may scrape the coating or shear the guide wire. A catheter, introducer sheath or vessel dilator should replace the needle as soon as the guide wire has been inserted in the vessel.
- It is recommended that a plastic torque device be used to handle the ZIPwire Hydrophilic Guide Wire. Use of a metal torque device may damage the wire. Also, do not slip a tightened torque device over the ZIPwire Hydrophilic Guide Wire, as this may damage the wire.
Potential Adverse Effects
Potential adverse events (in alphabetical order) that may be associated with the use of a guide wire include, but are not limited to, the following: allergic reaction, amputation, death, delayed immune response, embolism, febrile reaction, hematoma, hemorrhage, infection, myocardial ischemia and/or infarction, pseudoaneurysm, renal failure, stroke, vascular thrombosis, vessel occlusion, vessel perforation, dissection, trauma or damage, vessel spasm.
Cautions
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Trademark
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