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

Model Number CQF7584

Device Problems Deflation Problem (1149); Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

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: 07/2023).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had a deflation problem.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had a deflation problem.There was no reported patient injury.

Manufacturer Narrative

H10: 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: one conquest pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared bloody, and the proximal end of the balloon has noted to be twisted and tightly folded.No other anomalies were noted.During the functional evaluation the guide wire lumen was flushed, and water exited out of the distal tip, an in-house guide wire was able to insert through the catheter without any issue.The balloon was then inflated with in-house presto device, but only the distal of the balloon inflated and water exited through the distal tip.The proximal end of the balloon was wiggled and maneuvered but it did not inflate as more pressure was added to the balloon, water however exited more from the distal end.The balloon fiber was removed, and the balloon was inflated again, and it was noted to have two pinhole ruptures on the balloon and the inflation port was noted to be collapsed.All the anomalies were observed in the microscopic observation.The investigation is confirmed for the identified balloon rupture as pin hole ruptures were noted on the balloon water leaks from the balloon when inflated.The investigation is also confirmed for the identified inflation issue as the proximal end of the balloon didn¿t inflate when the balloon attempts to inflates multiple times and also the inflation port was noted be collapsed when the balloon fibers were removed.The investigation for the reported deflation issue is also confirmed for, as the inflation port was noted to be collapsed, which may contributed to the reported issue.The collapsed inflation port noted during the evaluation most likely contributed to the reported deflation and inflation issue.However the definitive root for the alleged deflation issue and identified balloon rupture and inflation issue 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.H10: d4 (expiry date: 07/2023).H11: section a through f ¿ 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.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11420730
• MDR Text Key: 238366835
• Report Number: 2020394-2021-00454
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060557
• UDI-Public: (01)00801741060557
• Combination Product (y/n): N
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CQF7584
• Device Catalogue Number: CQ7584
• Device Lot Number: REEV3423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other