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

Model Number	H74939347070450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a mildly tortuous and severely calcified vessel.A 7.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilation.During first inflation at 30 atmospheres, the balloon ruptured.The device was removed using normal method without issue.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for analysis and underwent visual inspection.Findings revealed that the balloon was not folded, which suggests exposure to positive pressure prior to return.According to athletis specifications, the rated burst pressure of this device is 34 atmospheres.The returned device was connected to an encore inflation system, and positive pressure was applied during testing.Liquid leakage was observed emanating from a pinhole defect located approximately 4 mm distal to the distal marker band.A combined visual and tactile examination of the device shaft revealed no evidence of kinking or structural damage.Similarly, a visual and tactile assessment of the distal tip showed no signs of damage or deformation.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a mildly tortuous and severely calcified vessel.A 7.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilation.During first inflation at 30 atmospheres, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with this 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: 21900659
• Report Number: 2124215-2025-25134
• Device Sequence Number: 17198929
• Product Code: LIT
• UDI-Device Identifier: 08714729973904
• UDI-Public: (01)08714729973904(17)280120(10)35667417
• 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): 06/03/2025

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: H74939347070450
• Device Catalogue Number: H74939347070450
• Device Lot Number: 0035667417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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: RADIFOCUS; GUIDEWIRE: RADIFOCUS; INTRODUCER SHEATH: 6F SHEATH; INTRODUCER SHEATH: 6F SHEATH
• Patient Sex: Unknown