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

Model Number	H74939347080450
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual examination identified that the balloon was not folded, indicating that the balloon had been subjected to positive pressure.The returned device was connected to an encore inflation unit.Positive pressure was applied, during which liquid leakage was observed originating from a pinhole in the balloon located approximately 2 mm distal to the distal marker band.Visual and tactile examination identified no kinks, leaks, or damage to the device shaft.Visual and tactile examination also identified no damage to the device tip.
Event or Problem Description
It was reported that pinhole noted occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified upper arm cephalic vein.An 8.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilatation.During the procedure, pinhole damage was noted on the shaft.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that pinhole noted occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified upper arm cephalic vein.An 8.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilatation.During the procedure, pinhole damage was noted on the shaft.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 23632627
• Report Number: 2124215-2025-85626
• Device Sequence Number: 16047435
• Product Code: LIT
• UDI-Device Identifier: 08714729974048
• UDI-Public: (01)08714729974048(17)280415(10)36311018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/07/2026

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: H74939347080450
• Device Catalogue Number: H74939347080450
• Device Lot Number: 0036311018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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