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

Model Number ATG80144

Device Problems Material Frayed (1262); Inflation Problem (1310); Material Rupture (1546); Unraveled Material (1664); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2023).

Event Description

It was reported that during an angioplasty procedure, there was a band or some of the carbon fibers knotted and the device allegedly failed to inflate.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, there was a band or some of the carbon fibers knotted and the device allegedly failed to inflate.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared bloody.Unraveled fiber and fiber disturbance has noted on the balloon.No other specific anomalies noted.On the functional evaluation of device, the balloon was inflated with the in-house presto device, upon inflation water was noted on the pin-hole balloon rupture.Microscopic observation was made to observe the anomalies.One photo was reviewed.The balloon appeared bloody and a fiber was unraveled form the balloon and middle portion of the balloon noted to be deformed which looks like tied up with the fiber.Therefore, based on the photo review, the reported failure inflation issue and unraveled fiber can be confirmed.Therefore, the investigation was confirmed for the reported inflation issue, as due to the tightening of the unraveled fibers noted on the device returned for evaluation.The investigation was confirmed for the reported unraveled fiber as these anomalies noted on the device and the submitted photo also confirms.The investigation also confirmed for the identified balloon rupture as the water leaks from the pin-hole balloon rupture.The unraveled fibers are the likely cause of the uneven inflation problem leads to the reported inflation issue.However, the definitive root cause for the alleged inflation issue, unraveled fiber and identified balloon rupture could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 06/2023), g3 h11: h6 (device, result, conclusion) h11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.See h10.

• 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: 10933411
• MDR Text Key: 219131401
• Report Number: 2020394-2020-20725
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• 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: 05/18/2021

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 Model Number: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93SE0050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other