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)

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 unable to inflate.It was further reported that the device had deflation problem.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 device was returned for evaluation.The sample appeared to be bloody.Fiber disturbance and balloon was noted to be slightly prolapsed at the distal tip of balloon.Using in house presto device balloon inflated which held pressure with no issue.Balloon took more than a minute to deflate.Balloon was cut and under microscopic evaluation the catheter was noted to be collapsed at both port holes.Therefore the investigation is confirmed for the reported inflation and deflation problem as collapsed port holes were noted.The investigation is also confirmed for the identified frayed material issue as fiber disturbance was noted.However the cause of the collapsed ports and the definitive root cause for the inflation issue, deflation problem and the frayed material issue could not be determined based upon available 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), g3 h11: h6 (method, result, conclusion) 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.See h10.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly unable to inflate.It was further reported that the device had deflation problem.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: 11277338
• MDR Text Key: 230239403
• Report Number: 2020394-2021-00126
• 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: 03/25/2021

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
• 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
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other