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

Model Number U41501Q1HRX

Device Problems Material Rupture (1546); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the malfunction and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definitive root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u41501q1hrx pta balloon dilatation catheter allegedly experienced failure to advance and balloon rupture.This information was received from one source.This malfunction involved one patient with no consequences.The female patient's age and weight is unknown.

• 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: 10310252
• MDR Text Key: 199977901
• Report Number: 2020394-2020-04950
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741055546
• UDI-Public: (01)00801741055546
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U41501Q1HRX
• Device Catalogue Number: U41501Q1HRX
• Device Lot Number: CMDV0277
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1