MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER

Model Number U41502H10

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

One device was returned to bd for evaluation.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction event.A review of the events indicated that model u41502h10 pta balloon dilatation catheter experienced peeled material.This report was received from one source.This event did not involve a patient; therefore, patient identifiers are not required.

Manufacturer Narrative

The device has been returned for evaluation; the investigation is inconclusive for the reported peeling issue as no such failure was identified in sample evaluation.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction event.A review of the events indicated that model u41502h10 pta balloon dilatation catheter experienced peeled material.This report was received from one source.This event did not involve a patient; therefore, patient identifiers are not required.

• Brand Name: ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• MDR Report Key: 8515652
• MDR Text Key: 142409140
• Report Number: 2020394-2019-00307
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741053566
• UDI-Public: (01)00801741053566
• 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: 07/23/2019

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: U41502H10
• Device Catalogue Number: U41502H10
• Device Lot Number: CMCZ0374
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 06/30/2019
• Supplement Dates FDA Received: 07/23/2019
• Patient Sequence Number: 1