MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Atlas; PTA Balloon Dilatation Catheter

Catalog Number	AT75144
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient was prepped for a percutaneous transluminal angioplasty (pta) procedure using an atlas balloon catheter.Prior to the procedure, it was noted that the balloon catheter had become disconnected from the sheath.It was further reported that the balloon had partially detached from the device while remaining partially attached.It was broken before they used it.The procedure was subsequently completed using an alternative device.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: received one atlas pta dilatation catheter for evaluation.Upon visual evaluation, the balloon appeared to be folded and unused, however bunched balloon material was noted to the folded balloon material from the distal tip.No other anomalies were noted to the device.During functional testing, the balloon joints were examined under magnification, and no breaks were noted to the joints.No other breaks were noted to the device.No functional testing was performed.Therefore, the investigation is confirmed for the identified material deformation as the bunched balloon material was noted.However, the investigation is unconfirmed for the reported break as no breaks were noted to the device.A definitive root cause for the reported break and identified material deformation 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.B5, d2b (dqy; lit), g3, h6 (device, method, result).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 AZ 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50078385
• Report Number: 2020394-2026-01962
• Device Sequence Number: 10219064
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438(11)260605(17)290228(10)RELQ3245
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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: AT75144
• Device Lot Number: RELQ3245
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 09/07/2026; 09/25/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/08/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2026
• 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