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.
Conclusion: the device was returned for evaluation.
A visual inspection found unraveled and frayed fibers along the length of the balloon.
The balloon was inflated and took an asymmetric shape due to the constricting, unraveled fibers.
Additionally, a longitudinal rupture was identified on the barrel of the balloon.
Therefore, the investigation is confirmed for the frayed and unraveled fibers.
The investigation is also confirmed for material deformation as well as for a longitudinal rupture.
Per the reported event details, the balloon was being used to treat an in stent restenosis.
It is possible that an interaction with the stent contributed to the reported and identified issues.
However, the definitive root cause could not be determined based upon available information.
Labeling review: the current ifu (instructions for use) states: warnings: 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.
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.
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 still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.
(b)(4).
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No hospital/medical records or medical images have been made available to the manufacturer.
As the lot number for the device was provided, a review of the device history records is currently being performed.
The device has been returned to the manufacturer for evaluation.
The investigation of the reported event is currently underway.
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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