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	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalic arch.An 8.0mm x 40mm x 50cm athletis balloon catheter was advance for dilation.During the procedure, the balloon ruptured upon first inflation at 25 atmospheres for several seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There was no patient complications noted as a result of this event, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalic arch.An 8.0 mm x 40 mm x 50 cm athletis balloon catheter was advance for dilation.During the procedure, the balloon ruptured upon first inflation at 25 atmospheres for several seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There was no patient complications noted as a result of this event, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Device evaluated by mfr: the 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.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 2mm distal from the distal markerband.A visual and tactile examination identified no kinks or damage to the shaft and tip of the device.The reported event was confirmed.

• 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: 22106271
• Report Number: 2124215-2025-29258
• Device Sequence Number: 17898262
• Product Code: LIT
• UDI-Device Identifier: 08714729974048
• UDI-Public: (01)08714729974048(17)271216(10)35497431
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 0035497431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 018 GUIDEWIRE; GUIDEWIRE: 018 GUIDEWIRE; INFLATION DEVICE: NIPRO; INFLATION DEVICE: NIPRO; INTRODUCER SHEATH: 7F3 CM; INTRODUCER SHEATH: 7F3 CM
• Patient Sex: Unknown