MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA BALLOON DILATATION CATHETER

Catalog Number	CQF7554
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted as the lot number was unknown.Visual inspection: the sample was not returned; therefore, visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Conclusion: the investigation was inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon the available information.It was unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: to reduce the potential for stent or stent graft damage and/or vessel damage from the stent or stent graft, the diameter of the balloon should be no greater than the diameter of the stent or stent graft.Refer to the stent or stent graft ifu for safety information including the warnings, precautions and potential adverse effects regarding the use of balloon post-dilatation.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.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.
Event or Problem Description
It was reported that during an angioplasty procedure, the guidewire, and the sheath were allegedly difficult to advance in the cephalic arch stenosis; however, the health care provider (hcp) was able to reach the lesion.It was further reported that the hcp then decided not to use this device and retracted it with alleged difficulty.Reportedly, another pta balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: CONQUEST 40 PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6117453
• Report Number: 2020394-2016-01090
• Device Sequence Number: 894030
• Product Code: DQY
• UDI-Device Identifier: 00801741060397
• UDI-Public: (01)00801741060397
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CQF7554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 55