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

Model Number	H74939347080450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalic vein upper arm.An 8.0 mm x 40 mm x 50cm athletis balloon catheter was advanced for dilatation.During the second inflation, the balloon ruptured.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.B5 - describe event or problem: updated to include new information obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalic vein upper arm.A 8.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilatation.During the second inflation, the balloon ruptured.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the patient's anatomy was challenging, possibly due to calcification.The balloon was inflated to 20 atmospheres, but the rupture occurred on the second inflation, for which the nominal pressure was unknown.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.B5 - describe event or problem: updated to include new information obtained.An athletis device was returned for analysis.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 31 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 1mm distal from the proximal markerband.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalic vein upper arm.A 8.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilatation.During the second inflation, the balloon ruptured.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the patients anatomy was challenging, possibly due to calcification.The balloon was inflated to 20 atmospheres, but the rupture occurred on the second inflation, for which the nominal pressure was unknown.

• 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: 23567480
• Report Number: 2124215-2025-83373
• Device Sequence Number: 13300745
• 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,Followup
• Report Date (Section B): 12/15/2025

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: 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: 10/29/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 12/11/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 11/24/2025; 12/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: FUGA018; GUIDEWIRE: FUGA018; GUIDEWIRE: FUGA018; GUIDEWIRE: FUGA018; INFLATION DEVICE: NIPRO; INFLATION DEVICE: NIPRO; INFLATION DEVICE: NIPRO; INFLATION DEVICE: NIPRO; INTRODUCER SHEATH: 7F3CM; INTRODUCER SHEATH: 7F3CM; INTRODUCER SHEATH: 7F3CM; INTRODUCER SHEATH: 7F3CM
• Patient Sex: Unknown