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

Model Number CQF7584

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned for evaluation.However, 6 photos were provided for one of the devices.A lot history review was performed.The investigation confirmed the device markings issue for on device.This issue is inconclusive for the remaining 5 devices.The investigation was not able to determine a root cause.The device was labeled for single use.

Event Description

This report summarizes 6 malfunctions.A review of the events indicated that model cqf7584 experienced a device markings issue.These reports were received from various sources.The six devices were not used in the patient.

• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8822917
• MDR Text Key: 152087140
• Report Number: 2020394-2019-01804
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060557
• UDI-Public: (01)00801741060557
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2019

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: CQF7584
• Device Catalogue Number: CQF7584
• Device Lot Number: REDQ3444
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/24/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1