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

Catalog Number	ATG80166
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one atlas gold pta dilatation catheter.Upon visual inspection the balloon appeared to have residue throughout.No anomalies noted to the y-body.During functional testing the device guidewire lumen was flushed.The patency of the guidewire lumen was tested using an in-house guidewire, and it was able to be inserted with some slight resistance on the kink near the proximal end.An in-house presto inflation device was used to inflate the device, and water was noted to be leaking from the balloon from the distal tip.In addition, water was leaking from the distal tip of the catheter.Under microscopic examination, a circumferential rupture was noted to the balloon.Then to find the source of the leak from the distal tip, the balloon was cut to reveal the inner gw lumen.It was noted there was a break on the gw lumen on the proximal end of the balloon.The break was the source of the kink initially seen.In addition, the glue bullet was pulled from the outer catheter.No further functional testing was performed.One video was provided and reviewed.The video shows healthcare professional holding the atlas gold balloon.When hcp try to inflate the balloon, the water was noted to be leaking in the distal tip of the balloon.Blood residues were noted throughout the balloon.No other anomalies noted.Therefore, the investigation is confirmed for the reported leak as the water was leaking from the distal tip of the balloon.The investigation is confirmed for the identified break as the break on the gw lumen on the proximal end of the balloon and also the investigation is confirmed for the identified circumferential rupture was noted to the balloon.A definitive root cause for the reported leak and identified circumferential rupture and break could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D2b (dqy; lit).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.
Event or Problem Description
On (b)(6) 2025, a 62-year-old female patient underwent an angioplasty procedure for central vein stenosis in femoral vein using the atlas gold pta balloon.During the procedure, the balloon allegedly leaked from the tip.The procedure was completed using another balloon.There was no reported patient injury.

• 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: 24017288
• Report Number: 2020394-2025-02360
• Device Sequence Number: 21075388
• Product Code: LIT
• UDI-Device Identifier: 00801741060830
• UDI-Public: (01)00801741060830(17)261212(10)93ZH0056
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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 Catalogue Number: ATG80166
• Device Lot Number: 93ZH0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2025
• Initial Report FDA Received Date: 01/09/2026
• 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 Age: 62 YR
• Patient Sex: Female