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

Model Number	H74939347120470
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the central vein.A 12.0mm x 40mm x 75cm athletis balloon catheter was selected for use in an arteriovenous fistula percutaneous transluminal angioplasty (pta).During third inflation at nominal atmospheres, the balloon ruptured.Contrast leakage was confirmed, and the balloon was removed.The procedure was completed a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the central vein.A 12.0mm x 40mm x 75cm athletis balloon catheter was selected for use in an arteriovenous fistula percutaneous transluminal angioplasty (pta).During third inflation at nominal atmospheres, the balloon ruptured.Contrast leakage was confirmed, and the balloon was removed.The procedure was completed a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the athletis device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 6mm in length and was located in the mid region of the balloon.A visual and tactile examination identified a shaft kink approximately 275 mm distal from the distal end of the strain relief.A visual examination found no issues or damage to the tip or marker bands of the device.This concludes the product analysis.
Additional Manufacturer Narrative
Device evaluated by mfr: the athletis device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 6mm in length and was located in the mid region of the balloon.A visual and tactile examination identified a shaft kink approximately 275 mm distal from the distal end of the strain relief.A visual examination found no issues or damage to the tip or marker bands of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the central vein.A 12.0mm x 40mm x 75cm athletis balloon catheter was selected for use in an arteriovenous fistula percutaneous transluminal angioplasty.During third inflation at nominal atmospheres, the balloon ruptured.Contrast leakage was confirmed, and the balloon was removed.The procedure was completed a different device.There were no patient complications as a result of this event.It was further reported that patient had complex anatomy, heavily calcified lesion, and patient factors contributed to the reported 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: 23310869
• Report Number: 2124215-2025-71356
• Device Sequence Number: 5789206
• Product Code: LIT
• UDI-Device Identifier: 08714729974260
• UDI-Public: (01)08714729974260(17)260319(10)31262304
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/15/2026

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 Expiration Date: 03/19/2026
• Device Model Number: H74939347120470
• Device Catalogue Number: H74939347120470
• Device Lot Number: 0031262304
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 12/21/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/29/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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 Age: 47 YR
• Patient Sex: Male