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

Model Number CQ7574

Device Problems Material Frayed (1262); Material Rupture (1546); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, the devices were returned to bd.The company is still investigating the issue at this time.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq7574.Pta balloon dilatation catheter allegedly experienced material rupture.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

Manufacturer Narrative

H10: for the reported event, lot number was provided, and a lot history review was perfomed.The sample was returned for evaluation.Balloon rupture, frayed fibers and material deformation was confirmed for the device.A root cause has not been determined.The device was labeled for single use.H10: g4.H11: h6 (results, conclusion).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq7574.Pta balloon dilatation catheter allegedly experienced material rupture.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• 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: 9198106
• MDR Text Key: 162621628
• Report Number: 2020394-2019-04000
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062995
• UDI-Public: (01)00801741062995
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQ7574
• Device Catalogue Number: CQ7574
• Device Lot Number: RECZ3450
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1