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

Model Number	ATG120144
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 loaded onto a packaging hoop with a balloon rewrap tool has been received for the evaluation.On the visual evaluation, the balloon was noted to have the peeled pebax , no other anomalies were noted to the sample.On the functional evaluation, an in-house presto inflation device was used to inflate the balloon.Then the water was noted leaking throughout the whole balloon.Under the microscopic observation, the balloon was re-examined after inflation and more peeled peebax was noted.No other functional testing performed.Therefore the investigation the reported balloon rupture was confirmed as the water starts leaking throughout the whole balloon upon inflation.The investigation for the identified peeled pebax was confirmed as the pebax was noted on the balloon under the microscopic observation.A definitive root cause for the reported balloon rupture and the identified unraveled fibers, peeled pebax could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 08/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12552061
• Report Number: 2020394-2021-01820
• Device Sequence Number: 4032217
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: ATG120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93UE0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 60