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

Model Number CQ7578

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device is return for the one complaint.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq7578.Pta balloon dilatation catheter allegedly experienced a material rupture.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.

Manufacturer Narrative

H10:for the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The investigation is confirmed for fiber disturbance and frayed fibers and was also confirmed for a longitudinal rupture.A root cause has not been determined.The device is labeled for single use.H11: h6 (results, conclusion) 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq7578.Pta balloon dilatation catheter allegedly experienced a material rupture.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.

• 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: 8816768
• MDR Text Key: 151884371
• Report Number: 2020394-2019-01746
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063015
• UDI-Public: (01)00801741063015
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQ7578
• Device Catalogue Number: CQ7578
• Device Lot Number: RECZ1568
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1