MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U3513034

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The sample was not returned; however a photo has been provided and reviewed.The investigation reported issue was confirmed for the detachment.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 u3513034 035 pta catheter allegedly experienced damage prior to use and detachment.This information was received from one source.This malfunction did not involve patient.Age, weight, and gender of the patient was not provided.

• Brand Name: ULTRAVERSE 035 PTA 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: 10305099
• MDR Text Key: 199843007
• Report Number: 2020394-2020-04773
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741091674
• UDI-Public: (01)00801741091674
• 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: 07/21/2020

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 Model Number: U3513034
• Device Catalogue Number: U3513034
• Device Lot Number: CMCV0174
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1