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

Model Number U4150315RX

Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided and a lot history review was performed.The investigation is inconclusive for the reported guidewire issue, catheter kink and advancement issue, as the device was not returned for evaluation.The definitive root cause for the reported guidewire issue, catheter kink and advancement issue could not be determined based upon available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u4150315rx pta balloon dilatation catheter allegedly experienced failure to advance, device-device incompatibility, and material deformation.This information was received from one source.One patient was involved and there was no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) kgs.

• 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: 9216277
• MDR Text Key: 163124967
• Report Number: 2020394-2019-04215
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056956
• UDI-Public: (01)00801741056956
• 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: 10/21/2019

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: U4150315RX
• Device Catalogue Number: U4150315RX
• Device Lot Number: CMDQ0320
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/21/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1