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

Model Number	H74939347080470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the brachial cephalic vein.An 8.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilation.During 7th inflation at 30 atmospheres for 30 seconds, the balloon ruptured in a pinhole form at around the center.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.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the brachial cephalic vein.An 8.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilation.During 7th inflation at 30 atmospheres for 30 seconds, the balloon ruptured in a pinhole form at around the center.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.It was further reported that the target lesion was 90% stenosed, mildly tortuous and severely calcified.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the brachial cephalic vein.An 8.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilation.During 7th inflation at 30 atmospheres for 30 seconds, the balloon ruptured in a pinhole form at around the center.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.It was further reported that 90% target lesion was located in the mildly tortuous and severely calcified brachial cephalic vein.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the athletis was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A leak test identified a balloon pinhole located at the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.

• 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: 21853506
• Report Number: 2124215-2025-22738
• Device Sequence Number: 12913599
• Product Code: LIT
• UDI-Device Identifier: 08714729974055
• UDI-Public: (01)08714729974055(17)271129(10)35389151
• 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): 06/16/2025

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: H74939347080470
• Device Catalogue Number: H74939347080470
• Device Lot Number: 0035389151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 05/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/19/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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