Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.
This lot met all release criteria.
There was nothing found to indicate there was a manufacturing related cause for this event.
This is the only complaint reported to date for this lot number and failure mode investigation summary: the device was returned for evaluation.
A visual inspection identified a complete circumferential rupture in the balloon.
Additionally, the balloon material was bunched at the distal tip.
Stretching was noted throughout the inner guidewire lumen, and the distal marker band was dislodged due to the stretching.
The distal tip of the returned sheath was slightly deformed.
Based on the stretching, bunched balloon material, and damage to the returned sheath, the investigation is confirmed for the reported retraction issues.
Additionally, the investigation is confirmed for a complete circumferential balloon rupture, and for a dislodged marker band.
It is likely that the circumferential rupture led to the retraction issues and dislodged marker band, based on the stretched lumen, bunching of the balloon material at the distal end of the device, and damage to the users returned sheath.
However, the definitive root cause for the circumferential rupture could not be determined based upon the available information.
Labeling review: the current ifu (instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.
Do not advance or retract the catheter unless the balloon is fully deflated.
If resistance is met during manipulation, determine the cause of the resistance before proceeding.
Applying excessive force to the catheter can result in tip breakage or balloon separation.
Do not exceed the rbp recommended for this device.
Balloon rupture may occur if the rbp rating is exceeded.
To prevent over pressurization, use of a pressure monitoring device is recommended.
Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.
If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.
If resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter, introducer sheath and guidewire (as necessary) as a single unit.
Use of the rival pta dilatation catheter: while maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the sheath and withdraw the deflated dilatation catheter over the wire through the introducer sheath.
Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.
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No hospital/medical records or medical images have been made available to the manufacturer.
The lot number for the device was not provided; therefore, a review of the device history records could not be performed.
The return of the device is pending.
The results of the anticipated device evaluation will be provided upon completion of the event investigation.
The information provided by bard represents all of the known information at this time.
Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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