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

Catalog Number	ATG120144
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
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 return of the sample is pending.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 was undergoing a percutaneous transluminal angioplasty (pta) procedure using the atlas gold balloon catheter.During the procedure, it was reported that the balloon catheter was not deflating fully and allegedly stuck inside the sheath.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 atlas gold pta dilatation catheter returned for evaluation.Upon visual inspection, it was noted there was hard dried contrast/saline within the balloon near the distal tip.No anomalies noted to the luers or 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 sheath was flushed.Using an in-house presto inflation device, the balloon was subjected to negative pressure, however it was noted the distal portion of the balloon had hard contrast/saline that felt rocklike.An attempt was made to insert the balloon through the sheath but could not be inserted past the dried contrast.The balloon was retracted and inflated to nominal pressure.The balloon was successfully inflated and maintained pressure.The balloon was then deflated, and it took approximately 24 seconds to fully deflate.The contrast was still present but felt smaller than initially as some had dissolved during inflation.An attempt was made to insert the balloon through the in-house sheath, and it was able to be inserted with some slight resistance.The balloon was inflated to nominal pressure and deflated without issue.The balloon catheter was retracted without no issue through the sheath.No other functional testing performed.Therefore, the investigation is unconfirmed for the reported deflation issue as balloon was deflated without issues.Also, the investigation is unconfirmed for the reported sheath removal issues as balloon catheter was retracted without issue through the introducer sheath.A definitive root cause for the reported deflation problem and sheath removal difficulties 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), e1, g3, h6 (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 was undergoing a percutaneous transluminal angioplasty (pta) procedure using the atlas gold balloon catheter.During the procedure, it was reported that the balloon catheter was not deflating fully and allegedly stuck inside the sheath.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: 23130512
• Report Number: 2020394-2025-01563
• Device Sequence Number: 7394292
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762(17)280612(10)93TK0066
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/26/2025

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: ATG120144
• Device Lot Number: 93TK0066
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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