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

Catalog Number ATG120144

Device Problems Inflation Problem (1310); Peeled/Delaminated (1454); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

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.The information provided by bard represents all of 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 bard.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had difficulty inflating.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had difficulty inflating.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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.An inflation attempt was made and a pinhole rupture was noted on the distal cone as well as peeled pebax at the same location.The balloon was unable to be fully inflated.Therefore, the investigation is confirmed for the reported inflation issue, pinhole rupture and peeled pebax.The identified pinhole rupture likely was the cause of the inflation issue, as a rupture would not allow the device to adequately pressurize.Because the peeling pebax was noted at the location of the rupture, it is unknown if the rupture caused or contributed to the peeling pebax.The definitive root cause for the identified issues 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.

• 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: 7877304
• MDR Text Key: 120394143
• Report Number: 2020394-2018-01696
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (y/n): N
• PMA/PMN Number: K122984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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: 04/18/2021
• Device Catalogue Number: ATG120144
• Device Lot Number: 93RC0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1