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); Retraction Problem (1536)

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 failed to inflate and retraction 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 was returned for the evaluation.Visual evaluation was performed and noted that sample was bloody and the balloon appeared to be tightly twisted and folded , it might be due to shipping or improper handling of the device.No any other anomalies to be noted.During the functional test, in-house gw was advanced from the distal tip to exit out of the gw luer.The balloon was inflated using an in-house presto inflation device to a nominal pressure but it would not inflate.The proximal glue joint was wiggled and maneuvered to undo the twisting on the balloon which allowed the balloon to partially inflate.Another attempt was made to inflate but the balloon only partially inflated.Then the catheter was attempted to be retracted through the sheath but was unsuccessful since balloon was partially inflated.Then balloon was cut to expose the inflation holes and was observed under the microscope and the inflation port was noted to be slightly collapsed.Therefore, the investigation is confirmed for the reported inflation problem as device was not able to be inflated completely during evaluation.The investigation is confirmed for the identified deflation problem as device was not able to be fully deflated during evaluation.The investigation is also confirmed for the reported retraction issue as device was noted to have difficulty retracting through in house guidewire during evaluation.The collapsed inflation holes noted under magnification most likely contributed to the reported inflation and deflation issue.However the definitive root cause for the reported inflation problem, deflation problem and retraction 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.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate and had a retraction problem.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: 11420980
• MDR Text Key: 238137379
• Report Number: 2020394-2021-00455
• 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: 04/13/2021

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