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

Model Number ATG120144

Device Problems Material Frayed (1262); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2018

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 iliac vein, the pta balloon allegedly had unraveled material.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: 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.Investigation summary: the device was returned for evaluation.A visual inspection found frayed fibers on the barrel of the balloon.Additionally, a loop of unraveled fibers was noted on the balloon.Therefore, the investigation is confirmed for both frayed and unraveled fibers.Per the reported event details, the device allegedly appeared to have been caught on a stent (wall stent).Therefore, it is likely that an interaction with the stent contributed to the identified fiber issues.However, the definitive root cause for the identified issues could not be identified 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.(expiry date: 09/2021).

Event Description

It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly had unraveled material.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ATLAS GOLD 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: 8177399
• MDR Text Key: 130895311
• Report Number: 2020394-2018-02216
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (y/n): N
• PMA/PMN Number: K181323
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATG120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93WC0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1