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

Catalog Number CQ75104J

Device Problems Deflation Problem (1149); Peeled/Delaminated (1454); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the conquest pta dilatation catheter that are cleared in the us.The product classification code for the conquest pta dilatation catheter product is identified.The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed for inflation problem, material rupture, peeled/delaminated.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq75104j pta balloon dilatation catheter allegedly experienced deflation problem, material rupture and peeled/delaminated.This information was received from one source.This malfunction involved one patient with no consequences.The patient's 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
• 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: 9973734
• MDR Text Key: 188901783
• Report Number: 2020394-2020-02971
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741127335
• UDI-Public: (01)00801741127335
• 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: 04/17/2020

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 Catalogue Number: CQ75104J
• Device Lot Number: RECZ0663
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/17/2020
• Type of Device Usage: N
• Patient Sequence Number: 1