MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number CQF7582

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Photos of the device have been provided for review.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 the package labeling for a model cqf7582 pta balloon dilatation catheter allegedly did not match the device inside the package.This information was received from a single source.There was no patient contact.The patient age, weight, and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cqf7584 pta balloon dilatation catheter allegedly experienced a device marking/labelling problem.This information was received from one source.There was no patient contact.No patient information was provided.

Manufacturer Narrative

The malfunction reported on this file was updated from cqf7582 to cqf7584.The lot number for the malfunction was provided and a lot history review was performed.The device and a photo has been returned for evaluation; the device and photo evaluation confirm a labelling issue.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.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.

• Brand Name: CONQUEST 40 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: 8822591
• MDR Text Key: 152072960
• Report Number: 2020394-2019-01793
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060533
• UDI-Public: (01)00801741060533
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQF7582
• Device Catalogue Number: CQF7584
• Device Lot Number: REDQ3444
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/11/2019
• Patient Sequence Number: 1