MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U813054

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review has been performed.The device was returned for evaluation and a rip was identified on the side of the packaging indicating a breach.The 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 u813054 pta balloon dilatation catheter allegedly experienced a packaging issue.This information was received from one source.There was no reported patient contact.Patient information was not provided.

• Brand Name: ULTRAVERSE 018 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: 9219898
• MDR Text Key: 163193616
• Report Number: 2020394-2019-04292
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741055126
• UDI-Public: (01)00801741055126
• 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

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U813054
• Device Catalogue Number: U813054
• Device Lot Number: CMDP0339
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1