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

Model Number CQF7584

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction and a lot history review was performed.One device was returned for evaluation.The investigation confirmed for material rupture and material frayed.A root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.The information reviewed indicated that model cqf7584 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no reported consequences.The male patient's age and weight were not provided.

• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9596608
• MDR Text Key: 178322757
• Report Number: 2020394-2020-00458
• Device Sequence Number: 1
• Product Code: DQY
• 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: 01/16/2020

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: RECR1037
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/16/2020
• Type of Device Usage: N
• Patient Sequence Number: 1