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

Model Number U4150430

Device Problems Peeled/Delaminated (1454); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the malfunction and a lot history review was performed.The device was returned for evaluation and the investigation confirmed peeled/delamination.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 u4150430 pta balloon dilatation catheter allegedly experienced material deformation and peeled/delaminated.The information was received from one source.The malfunction did not involve a patient.The patient was a (b)(6) female weighing 125lbs.

• Brand Name: ULTRAVERSE 014 PTA BALLOON DILATATION CATHETERS
• 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: 9975252
• MDR Text Key: 188887452
• Report Number: 2020394-2020-03011
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741064548
• UDI-Public: (01)00801741064548
• 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

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U4150430
• Device Catalogue Number: U4150430
• Device Lot Number: CMDQ0128
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1