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

Catalog Number	AT75124
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent percutaneous transluminal angioplasty (pta) procedure using the atlas balloon catheter.During the procedure, the balloon catheter allegedly unable to inflate.Therefore, unraveling and a partial break was detected at location of the water leaking from the proximal end of the balloon.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 pta dilatation catheter was returned for evaluation.Upon visual inspection, no kinks noted to the catheter shaft, no anomalies to the lures/y body.During functional testing, prior to testing an in-house presto inflation device was used to apply negative pressure to the balloon.With the same in-house presto inflation device, as the balloon was being inflated and water was noted leaking from the proximal end of the balloon.Under microscopic examination unraveling and a partial break was detected at location of the water leaking from the proximal end of the balloon.Therefore, the investigation is confirmed for the identified break and unraveled issues as unraveling, and a partial break was detected at location of the water leaking from the proximal end of the balloon.However, the investigation is unconfirmed for the reported inflation issues as the balloon was able to being inflate.A definitive root cause for the reported inflation problem and identified break and unraveling 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).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.

• Brand Name: ATLAS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 25574545
• Report Number: 2020394-2026-01583
• Device Sequence Number: 9065082
• Product Code: DQY
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407(17)280731(10)REKV0740
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: AT75124
• Device Lot Number: REKV0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/22/2026
• 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