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

Model Number U4150215RX

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.The sample was returned and a visual inspection was performed.A kink was noted approximately 32.5 cm from the distal tip.A kink was also noted at the proximal end of the balloon.No anomalies to the luers or bifurcate.The device was evaluated.Guidewire lumen and an in-house 4fr sheath was flushed, then inserted the guidewire.Balloon was aspirated prior to inserting into the sheath.Device was inserted into the sheath without issue, once inside of the sheath balloon was inflated/deflated without issue.Balloon retracted with out any issues.It is unknown whether patient and/or procedural factors contributed to the event.Based on the available information, 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 u4150215rx pta balloon dilatation catheter allegedly kinked at the proximal end of the shaft and was difficult to insert into the sheath.Another balloon was used to complete the procedure.There was no reported patient contact.This information was received from one source.The patient was an (b)(6) year-old female who weighed (b)(6) kilograms.

• 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 ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8817517
• MDR Text Key: 151925300
• Report Number: 2020394-2019-01760
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056291
• UDI-Public: (01)00801741056291
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U4150215RX
• Device Catalogue Number: U4150215RX
• Device Lot Number: CMDQ0371
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1