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

Model Number U8130415

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device for this malfunction has been returned to the manufacturer for evaluation. The investigation of the reported malfunction is currently underway. The device is labeled for single use.

Event Description

This report summarizes one malfunction. A review of the reported information indicated that model u8130415 pta balloon dilatation catheter allegedly experienced material puncture. This information was received from a single source. The malfunction involved a patient with no reported consequence. The patient was reported as a (b)(6)-year-old male whose weight was not provided.

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review. The sample was returned for evaluation. The investigation is unconfirmed for the reported guidewire issue. A root cause has not been determined. The device was labeled for single use.

Event Description

This report summarizes one malfunction. A review of the reported information indicated that model u8130415 pta balloon dilatation catheter allegedly experienced material puncture. This information was received from a single source. The malfunction involved a patient with no reported consequence. The patient was reported as a 65-year-old male whose weight was not provided.

• Brand Name: ULTRAVERSE 018 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8814310
• Report Number: 2020394-2019-01724
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741055065
• UDI-Public: (01)00801741055065
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: U8130415
• Device Catalogue Number: U8130415
• Device Lot Number: CMCT0503
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2019

Is This a Reprocessed and Reused Single-Use Device?