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

Catalog Number	ATG120126
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the atlas gold pta balloon.During the procedure, the balloon allegedly ruptured.Further, it was updated that they were able to find the hole in the balloon.The procedure was completed using another balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: manufacturing review: the lot history review determined this is the only complaint reported for this lot number to date.Investigation summary: one atlas gold pta balloon catheter returned for evaluation.Upon visual inspection, it was noted the balloon had blood residue.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 without issues.An in-house presto inflation device was used to inflate the device, and water was noted to be leaking from the balloon.Under microscope examination, a pinhole rupture was present on the balloon.No further functional testing was performed.Therefore, the investigation is confirmed for the reported balloon rupture as pinhole rupture was present on the balloon.A definitive root cause for the reported balloon rupture could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D2b (dqy; lit), g1, g3, h6 (method, result, conclusion).Section a through f - the information provided by bd 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 bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the atlas gold pta balloon.During the procedure, the balloon allegedly ruptured.Further, it was updated that they were able to find the hole in the balloon.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: 23460633
• Report Number: 2020394-2025-01841
• Device Sequence Number: 21434496
• Product Code: LIT
• UDI-Device Identifier: 00801741060724
• UDI-Public: (01)00801741060724(17)271028(10)93XJ0067
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/01/2025

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: ATG120126
• Device Lot Number: 93XJ0067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/09/2025
• 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: Unknown