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

Catalog Number	ATG120184
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 an angioplasty procedure using the atlas gold pta balloon.It was reported that during the procedure, the balloon allegedly detached.It was further reported that patient underwent surgical intervention (gastroscopy) to remove the balloon from the patient.The procedure was completed using another balloon.Current status of the patient is unknown.
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the atlas gold pta balloon.It was reported that during the procedure, the balloon allegedly detached.It was further reported that patient underwent surgical intervention (gastroscopy) to remove the balloon from the patient.The procedure was completed using another balloon.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported detachment as no objective evidence was provided for review.However, the investigation is confirmed for the reported user error of using a balloon catheter in an esophagus.A definitive root cause for the reported detachment issue 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.Per the reported information, the device was used in esophagus.Per the atlas gold ifu (baw1435900, rev.4) the atlas gold pta dilatation catheter is indicated for use in percutaneous transluminal angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.Therefore, the device was used in an esophagus was against the ifu and considered a user related issue.G3, h6 (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.

• 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: 23775742
• Report Number: 2020394-2025-02159
• Device Sequence Number: 10131367
• Product Code: DQY
• UDI-Device Identifier: 00801741060885
• UDI-Public: (01)00801741060885(11)240816(17)270814(10)93VJ0047
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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 Catalogue Number: ATG120184
• Device Lot Number: 93VJ0047
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/24/2026
• 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