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

Model Number U4150230RX

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the reported failure to advance and material deformation.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model u4150230rx ultraverse rx pta dilatation catheter allegedly experienced failure to advance and material deformation.The information was received from a single source.This malfunction involved one patient with no patient consequences.Patients' age, weight and gender were not provided.

• Brand Name: ULTRAVERSE RX 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: 10744139
• MDR Text Key: 213322178
• Report Number: 2020394-2020-06159
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056383
• UDI-Public: (01)00801741056383
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U4150230RX
• Device Catalogue Number: U4150230RX
• Device Lot Number: CMDY0052
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1