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

Catalog Number	CQ5054
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of a retrospective review of events that occurred in (b)(4) and in accordance with 21 c.F.R.Part 803, this event was assessed and determined to be mdr reportable.As the lot number for the device was provided, a review of the device history records is currently being performed.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.
Event or Problem Description
It was reported during an angioplasty procedure for av graft stenosis, the pta balloon was inflated approximately eight times in the venous side to approximately 20 atm's, and at the conclusion of the procedure, the outer material of the pta balloon was allegedly frayed after the catheter was removed from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the material review reports, raw material testing, manufacturing process, and quality control inspection.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 that has been reported for this corporate lot number to date.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: one electronic photo was reviewed.The photo shows the device laying coiled and appears to be partially inflated.Upon closer examination, material was seen partially peeled away from the fibers of the balloon on the distal balloon cone, as well as on the distal end of the balloon barrel.It is likely that the user perceived the peeled pebax material as frayed fibers.Therefore, the investigation is unconfirmed for the reported frayed material, and is confirmed for peeled pebax material.Conclusion: the definitive root cause for the peeled pebax could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current jifu ((b)(4) 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, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.Dilatation and deflation the balloon: while maintaining negative pressure and the position of the guidewire, withdraw the deflated dilatation catheter over the wire through the introducer sheath.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 during an angioplasty procedure for av graft stenosis, the pta balloon was inflated approximately eight times in the venous side to approximately 20 atm's, and at the conclusion of the procedure, the outer material of the pta balloon was allegedly frayed after the catheter was removed from the patient.There was no reported patient injury.

• Brand Name: CONQUEST 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: 6565093
• Report Number: 2020394-2017-00445
• Device Sequence Number: 18865549
• Product Code: DQY
• UDI-Device Identifier: 00801741062803
• UDI-Public: (01)00801741062803(17)181128(10)REZL0639
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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 Expiration Date: 11/28/2018
• Device Catalogue Number: CQ5054
• Device Lot Number: REZL0639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1