MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939347100470
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11-feb-2026.It was reported that balloon failed to inflate and a leak occurred.A 0.0mm x 40mm x 75cm athletis balloon was selected for use in a percutaneous transluminal angioplasty (pta) procedure.The target lesion was located in the subclavian vein, and was reported to be 80% stenosed with severe tortuosity and moderate calcification.During the procedure, it was noted that the balloon did not inflate.Upon withdrawal, a contrast agent leak from the balloon was observed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed a balloon pinhole.
Additional Manufacturer Narrative
With the available information, boston scientific concludes: investigation results: a visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A pinhole in the balloon material was identified, and the balloon could not be fully inflated, confirming the event.An examination of the tip, shaft, and marker bands found no issues.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review was completed and confirmed that the events of inflation problem and fluid/blood leak were defined in the athletis risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: boston scientific concludes the most probable root cause of adverse event related to patient condition.Based on the results of product analysis, and there being no reported device interaction, damage, or issue until inflation was attempted at the lesion site, it is suspected that patient anatomy and/or lesion characteristics most probably contributed to the balloon pinhole.

• Brand Name: ATHLETIS?
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24551848
• Report Number: 2124215-2026-12976
• Device Sequence Number: 9272220
• Product Code: LIT
• UDI-Device Identifier: 08714729974215
• UDI-Public: (01)08714729974215(17)261017(10)32662456
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K201170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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 Model Number: H74939347100470
• Device Catalogue Number: H74939347100470
• Device Lot Number: 0032662456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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 Age: 76 YR
• Patient Sex: Female