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

Catalog Number	ATG120164
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the atlas catheter to treat iliac vein stenosis.During the balloon removal, the balloon could not be gathered and retrieved normally at first.After continuing to attempt balloon removal, the balloon ruptured and was subsequently removed with a retrieval device.The current status of the patient is unknown.
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.Two photos were provided and reviewed.The first photo shows the atlas gold balloon and inner guidewire lumen noted to be detached from the device and also bunching was noted at the inner guidewire lumen.Partial inversion of balloon seen.The second photo shows the atlas gold device in which the balloon and inner guide wire lumen are completely detached from the catheter.Bunching was noted to the inner guidewire lumen.Blood residues were noted at the inflation luer and guidewire luer.The balloon is partially inverted.No other anomalies were noted.Therefore, the investigation is inconclusive for the reported balloon rupture as no objective evidence was provided for review.However, the investigation is confirmed for the identified detachment as the balloon and inner guidewire lumen were detached from the device.Also, the investigation is confirmed for the reported difficult to remove and identified material deformation as the inner guidewire lumen noted to be bunched, and balloon is partially inverted, which could have been caused due to removal difficulties.A definitive root cause for the reported balloon rupture, difficult to remove, identified deformation and detachment 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 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.
Additional Manufacturer Narrative
H10: 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.H11: d2b (dqy;lit).H11: 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 catheter to treat iliac vein stenosis.During the balloon removal, the balloon could not be gathered and retrieved normally at first.After continuing to attempt balloon removal, the balloon ruptured and was subsequently removed with a retrieval device.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.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.Two photos were provided and reviewed.The first photo shows the atlas gold balloon and inner guidewire lumen noted to be detached from the device and also bunching was noted at the inner guidewire lumen.Partial inversion of balloon seen.The second photo shows the atlas gold device in which the balloon and inner guide wire lumen are completely detached from the catheter.Bunching was noted to the inner guidewire lumen.Blood residues were noted at the inflation luer and guidewire luer.The balloon is partially inverted.No other anomalies were noted.Therefore, the investigation is inconclusive for the reported balloon rupture as no objective evidence was provided for review.However, the investigation is confirmed for the identified detachment as the balloon and inner guidewire lumen were detached from the device.Also, the investigation is confirmed for the reported difficult to remove and identified material deformation as the inner guidewire lumen noted to be bunched, and balloon is partially inverted, which could have been caused due to removal difficulties.A definitive root cause for the reported balloon rupture, difficult to remove, identified deformation and detachment 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), b1, b5, g2, g3, h1, h6 (patient) 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 catheter to treat iliac vein stenosis.During the balloon removal, the balloon could not be gathered and retrieved normally at first.After continuing to attempt balloon removal, the balloon ruptured and was subsequently removed with a retrieval device.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: 22042634
• Report Number: 2020394-2025-00758
• Device Sequence Number: 8908024
• Product Code: LIT
• UDI-Device Identifier: 00801741060823
• UDI-Public: (01)00801741060823(17)260303(10)93PH0189
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2026
• Device Catalogue Number: ATG120164
• Device Lot Number: 93PH0189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 08/20/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/04/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown