MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U41502H30

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for one of the two reported malfunctions was provided and a lot history review was performed.The device for one malfunction was not returned for evaluation, therefore the investigation is inconclusive for the reported failure.For the other malfunction, the device was returned and the investigation identified peeled outer layer.The definitive root cause is unknown.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model u4102h30 pta balloon dilatation catheter allegedly experienced peeled material.This information was received from various sources.Both events involved a patient with no reported patient injury.Patient age, weight, and gender were not provided.

• Brand Name: ULTRAVERSE 014 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): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9219899
• MDR Text Key: 163194899
• Report Number: 2020394-2019-04290
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741064449
• UDI-Public: (01)00801741064449
• 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: 10/22/2019

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: U41502H30
• Device Catalogue Number: U41502H30
• Device Lot Number: CMDT0579, UNKNOWN
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/22/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1