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

Model Number	H74939347100870
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11nov2025.It was reported that the balloon failed to inflate.A 10.0mm x 80mm x 75cm athletis balloon catheter was advanced for dilation.However, during inflation, it was noted that the pressure dropped just before reaching the pressure level.The procedure was resumed with the same device without any issues.There were no patient complications as a result of this event.However, device analysis revealed a balloon pinhole located approximately 4mm proximal from the distal markerband.
Additional Manufacturer Narrative
Device evaluated by mfr: the athletis device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 27 atmospheres as per athletis specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 4mm proximal from the distal markerband.A visual and tactile examination identified no kinks or damage to the shaft and tip of the device.This concludes the product analysis.

• 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: 23668452
• Report Number: 2124215-2025-85434
• Device Sequence Number: 15681057
• Product Code: LIT
• UDI-Device Identifier: 08714729974222
• UDI-Public: (01)08714729974222(17)271115(10)35289708
• 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): 11/27/2025

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 Model Number: H74939347100870
• Device Catalogue Number: H74939347100870
• Device Lot Number: 0035289708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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