MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA BALLOON DILATATION CATHETERS

Model Number U8150230

Device Problems Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The device was returned for evaluation and the investigation identified detachment of device or device component.A root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.The information reviewed indicated that model u8150230 pta balloon dilatation catheter allegedly experienced retraction problem, material rupture, and detachment of device or device component.The information was received from one source.The malfunction involved a (b)(6) year old male patient weighing (b)(6) kgs with no reported consequences.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.The device was returned for evaluation.Based on the sample evaluation, the investigation is confirmed for detachment, material deformation and guide wire issue; however, the investigation is inconclusive for material rupture and retraction issue.A definitive root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.The information reviewed indicated that model u8150230 pta balloon dilatation catheter allegedly experienced retraction problem, material rupture, and detachment of device or device component.The information was received from one source.The malfunction involved a 75 year old male patient weighing 75kgs with no reported consequences.

• Brand Name: ULTRAVERSE 018 PTA BALLOON DILATATION CATHETERS
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9975394
• MDR Text Key: 188733129
• Report Number: 2020394-2020-03033
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741064746
• UDI-Public: (01)00801741064746
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U8150230
• Device Catalogue Number: U8150230
• Device Lot Number: CMDU0242
• Date Manufacturer Received: 06/24/2020
• Patient Sequence Number: 1