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

Catalog Number	ATG80144
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway 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 patient underwent a percutaneous transluminal angioplasty (pta) procedure using the atlas gold pta balloon catheter.During the procedure, the circular relief on the surface of the balloon that hooked with the stent in the vessel.There was no reported patient injury.
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: the physical device was not returned for evaluation.One photo was provided and reviewed.The photo shows the atlas gold device.The balloon was seen inflated and circular deformation was seen in surface of the balloon.3-way stop cock was connected to the inflation luer.No other anomalies were noted.Therefore, the investigation is confirmed for the reported material deformation as a circumferential deformation was noted on the surface of the balloon.However, the investigation is inconclusive for the reported entrapment as no objective evidence was provided for review.A definitive root cause for the reported entrapment and material deformation 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), g3, h6 (device, component, method, result, conclusion) 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 patient underwent a percutaneous transluminal angioplasty (pta) procedure using the atlas gold pta balloon catheter.During the procedure, the circular relief on the surface of the balloon that hooked with the stent in the vessel.There was no reported patient injury.
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: one photo was provided and reviewed.The photo shows the atlas gold device.The balloon was seen inflated and circular deformation was seen in surface of the balloon.3-way stop cock was connected to the inflation luer.No other anomalies were noted.One atlas gold pta dilatation catheter returned for evaluation.Upon visual inspection, it was noted there was fiber disturbance in the middle of the balloon throughout the circumference of the balloon.The balloon was deflated but had hard dried contrast within the balloon and concentrated on the proximal end of the balloon.The device was returned with a 3-way stopcock.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, but it could not be inflated.It was noted the hard contrast within the balloon did not allow the balloon to inflate.The balloon was cut, and the dried saline contrast was noted within the balloon.No further functional testing was performed.Therefore, the investigation is confirmed for the reported material deformation as fiber disturbance was noted throughout the circumference of the balloon.However, the investigation is inconclusive for the reported entrapment as the conditions of use could not be replicated in the laboratory.A definitive root cause for the reported entrapment and material deformation 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.G3, h6 (method).Section a through f ¿ the information provided 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 patient underwent a percutaneous transluminal angioplasty (pta) procedure using the atlas gold pta balloon catheter.During the procedure, the circular relief on the surface of the balloon that hooked with the stent in the vessel.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): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22313115
• Report Number: 2020394-2025-00927
• Device Sequence Number: 8948389
• Product Code: DQY
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755(17)270711(10)93XJ0203
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 12/31/2025

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: ATG80144
• Device Lot Number: 93XJ0203
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 01/09/2026
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/03/2025; 01/12/2026
• 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 Sex: Unknown