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

Model Number CQ7584

Device Problems Deflation Problem (1149); Material Frayed (1262); Inflation Problem (1310); Retraction Problem (1536)

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

Event Date 01/08/2021

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 deflation problem.It was further reported that the device allegedly experienced difficulty in retracting the balloon through the sheath.The procedure was completed using another device.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 evaluation.On the functional evaluation of the device, it appeared bloody, frayed fibers were noted at the distal tip of the balloon.No other specific anomalies noted.On the functional evaluation of the device, an in-house guide wire is inserted without any issue, on further the balloon was aspirated before inserting into the in-house sheath and the balloon inserted into the sheath without any issue.Then the balloon attempted to inflates but it was unsuccessful.The balloon was cut and observed under microscope and it was noted that the glue bullet had migrated inside the inner catheter lumen.No further testing was performed.Therefore, the identified inflation issue is confirmed as attempts made to inflate the balloon was unsuccessful.The investigation also confirmed for the identified frayed material as noted in the distal tip of the balloon.However, the reported deflation issue and retraction issue remains inconclusive as the balloon didn¿t inflate to perform further functional testing and problem could not be reproduced in laboratory condition due to the condition of the device.The definitive root cause for the alleged deflation, retraction issue, identified frayed material 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 provided by bd 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 bd.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had deflation problem.It was further reported that the device allegedly experienced difficulty in retracting the balloon through the sheath.The procedure was completed using another device.There was no reported patient injury.

• 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: 11277316
• MDR Text Key: 230349400
• Report Number: 2020394-2021-00125
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CQ7584
• Device Catalogue Number: CQ7584
• Device Lot Number: REEV3423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR