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

Catalog Number	ATG80144
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not 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.D2b (dqy;lit).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 esophageal dilatation procedure by using an atlas gold balloon catheter.It was reported that during the procedure, the balloon allegedly failed to fully deflate as intended.As a result, the catheter had to be removed while partially inflated, causing some patient distress.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence provided for review.However, the investigation is confirmed for the incorrect use of device as it was used out of the device¿s intended purpose.A definitive root cause for the reported deflation 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.Atlas gold pta dilatation catheter instruction for use was reviewed.Instruction for use, the atlas gold pta dilatation catheter is intended for dilating stenoses in the peripheral vasculature and treating obstructive lesions of av fistulae.It is not indicated for use in coronary arteries or other non-peripheral locations.The reported use in the oesophageal canal is outside the device¿s intended purpose.This is therefore against the ifu and considered a use-related issue.D2b (lit; dqy), d1, d4 (medical device catalog number), d4 (medical device lot number), d4 (unique identifier (udi) #), g2, g3.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 esophageal dilatation procedure by using an atlas gold balloon catheter.It was reported that during the procedure, the balloon allegedly failed to fully deflate as intended.As a result, the catheter had to be removed while partially inflated, causing some patient distress.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence provided for review.However, the investigation is confirmed for the incorrect use of device as it was used out of the device¿s intended purpose.A definitive root cause for the reported deflation 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.Atlas gold pta dilatation catheter instruction for use was reviewed.Per instruction for use, the atlas¿ gold pta dilatation catheter is intended for dilating stenoses in the peripheral vasculature and treating obstructive lesions of av fistulae.It is not indicated for use in coronary arteries or other non-peripheral locations.The reported use in the esophageal canal is outside the device¿s intended purpose.This is therefore against the ifu and considered a use-related issue.G3, h6 (component, 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 esophageal dilatation procedure by using an atlas gold balloon catheter.It was reported that during the procedure, the balloon allegedly failed to fully deflate as intended.As a result, the catheter had to be removed while partially inflated, causing some patient distress.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: 23919801
• Report Number: 2020394-2025-02274
• Device Sequence Number: 18402400
• Product Code: LIT
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755(17)280807(10)93VK0024
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122984
• 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): 02/13/2026

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: 93VK0024
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 01/27/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/13/2026
• 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
• Patient Sex: Unknown