MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U4150230

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure in the tibial artery, the pta balloon had incompatibility issues with the guide wire.No further treatment was needed.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the tibial artery, the pta balloon had incompatibility issues with the guide wire.No further treatment was needed.There was no reported patient injury.

Manufacturer Narrative

The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Three segments of the device and one electronic video were returned and evaluated for evaluation.A visual inspection found a completed detachment in the outer catheter shaft.The detached distal portion of the catheter shaft and balloon was not returned.The inner guidewire lumen was found to be cut from the wire and was returned in two segments.Based on the video review, the device stuck on the guidewire could be confirmed.Therefore, the investigation is confirmed for the reported guidewire incompatibility.The investigation is also confirmed for catheter detachment.It is likely that the issues with the guidewire contributed to the outer catheter detachment.However, the definitive root cause for the identified guidewire issue could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).

• Brand Name: ULTRAVERSE 014 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: 7852763
• MDR Text Key: 119501457
• Report Number: 2020394-2018-01662
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741064425
• UDI-Public: (01)00801741064425
• Combination Product (y/n): N
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: U4150230
• Device Catalogue Number: U4150230
• Device Lot Number: CMCP0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 108