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

Model Number	ATG120182
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
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 was returned for evaluation.No specific anomalies were noted during the visual evaluation.In the functional testing, the balloon was inflated with an in-house presto inflation device and water was leaking from the balloon catheter.Under microscopic observation, a break was noted in the weld joint, which caused the leak during the testing.One photo and video was submitted for review.One photo was reviewed and the photo shows the balloon catheter in a deflated condition.No specific damage or any other anomalies were noted.One video was reviewed.And the video shows the balloon being in an inflated position, and a leak of fluid was able to be observed near the proximal end of the balloon and catheter.No specific damage could be noted on the balloon, and the source of the leak is unknown.Based on the photo review, the reported leak couldn¿t be confirmed.However, based on the video review and return sample analysis, the investigation for the reported leak is confirmed as the balloon was noted to be leaking from the proximal end of the balloon and the catheter was able to be noted during the functional evaluation.The investigation is also confirmed for the identified weld joint break, as during the microscopic observation a break was noted at the weld joint of the balloon, which caused the leak.During the microscopic observation, a weld joint break was noted at the balloon catheter that might have caused the reported leak.However, the definitive root cause for the reported leak and identified weld joint break 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: 04/2024.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon allegedly leaked.There was no patient contact.

• Brand Name: ATLAS GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15758123
• Report Number: 2020394-2022-00883
• Device Sequence Number: 15041069
• Product Code: DQY
• UDI-Device Identifier: 00801741060861
• UDI-Public: (01)00801741060861
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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: ATG120182
• Device Catalogue Number: ATG120182
• Device Lot Number: 93RG0164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female