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

Model Number U41502H22

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2018

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 upon removal from the packaging, frayed material was allegedly observed on the pta balloon.Another device was used to complete the procedure.There was no reported patient involvement.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot met all release criteria.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found frayed material near the proximal cone and distal tip.Therefore, the investigation is confirmed for the reported frayed material.The definitive root cause for the identified frayed material could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.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.

Event Description

It was reported that upon removal from the packaging, frayed material was allegedly observed on the pta balloon.Another device was used to complete the procedure.There was no reported patient contact.

• 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: 8220213
• MDR Text Key: 132203419
• Report Number: 2020394-2018-02274
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741053658
• UDI-Public: (01)00801741053658
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: U41502H22
• Device Catalogue Number: U41502H22
• Device Lot Number: CMCR0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1