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

Model Number	CQ75104
Medical Device Problem Codes	Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon outer layer allegedly unraveled.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned to the manufacturer for evaluation.Two photos were reviewed.The first photo shows that the device was noted bloody.The balloon was in deflated position and the peeled pebax was noted on the balloon, no other specific anomalies were noted.The second photo shows that the device was noted bloody.The balloon was inflated and the long strand of peeled pebax was noted from the middle of the balloon.Therefore, based on the photo review, the reported unraveled fiber was unconfirmed as there was no evidence of fiber disturbances noted on the submitted photo.However based upon the submitted photo, the identified peeled pebax can be confirmed.One conquest pta dilatation has been received for the evaluation.On the visual evaluation, the device appeared bloody and it was noted that the balloon had a peeled pebax at the distal end of the balloon , a long strand of peeled pebax was observed at the middle of the balloon and a lifted pebax at the proximal end of the balloon.No evidence for the fiber disturbances on the balloon and no other specific anomalies were noted.Under the microscopic observation, the peeled pebax was noted and examined.No other functional testing was performed.Therefore the investigation for the reported unraveled balloon fibers has been unconfirmed as there is no evidence for the unraveled fiber disturbances on the device returned for the evaluation and also in the submitted photo.The investigation for the identified peeled pebax was confirmed as the peeled pebax was noted on the balloon and it was also examined under the microscopic observation.A definitive root cause for the reported unraveled fibers and the identified peeled pebax could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.The information provide by bd represents all 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 bd.
Event or Problem Description
It was reported that during an angioplasty procedure through left brachial drainage vein, the pta balloon outer layer allegedly unraveled.There was no reported patient injury.

• Brand Name: CONQUEST PTA 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: 11154366
• Report Number: 2020394-2021-00024
• Device Sequence Number: 17170516
• Product Code: DQY
• UDI-Device Identifier: 00801741063220
• UDI-Public: (01)00801741063220
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/12/2021

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 Model Number: CQ75104
• Device Catalogue Number: CQ75104
• Device Lot Number: REDX1632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other