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

Model Number	H74939347070470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The 72% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalica antebrachii.A 7.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the second inflation while being inflated to 32 atmospheres for 30 seconds.The procedure was completed using another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The 72% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalica antebrachii.A 7.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the second inflation while being inflated to 32 atmospheres for 30 seconds.The procedure was completed using another of the same device.There were no patient complications as a result of this event.It was further reported that there were two devices used in the same one procedure.
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6) hospital.E1, initial reporter phone: (b)(6).The device was returned for analysis.Visual examination showed that the balloon was not folded, indicating exposure to positive pressure.A longitudinal tear was identified in the balloon material, measuring approximately 2 mm in length and located in the mid-region of the balloon.Visual and tactile examination revealed no kinks or damage to the shaft, and no damage to the tip was observed.
Event or Problem Description
It was reported that balloon rupture occurred.The 72% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalica antebrachii.A 7.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the second inflation while being inflated to 32 atmospheres for 30 seconds.The procedure was completed using another of the same device.There were no patient complications as a result of this event.It was further reported that there were two devices used in the same one procedure.It was further reported that the patient did not have significantly challenging anatomy.
Event or Problem Description
It was reported that balloon rupture occurred.The 72% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalica antebrachii.A 7.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the second inflation while being inflated to 32 atmospheres for 30 seconds.The procedure was completed using another of the same device.There were no patient complications as a result of this event.It was further reported that there were two devices used in the same one procedure.
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6).E1 - initial reporter phone: (b)(6).The device was returned for analysis.Visual examination showed that the balloon was not folded, indicating exposure to positive pressure.A longitudinal tear was identified in the balloon material, measuring approximately 2 mm in length and located in the mid-region of the balloon.Visual and tactile examination revealed no kinks or damage to the shaft, and no damage to the tip was observed.

• 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: 22967531
• Report Number: 2124215-2025-60315
• Device Sequence Number: 9109984
• Product Code: LIT
• UDI-Device Identifier: 08714729973911
• UDI-Public: (01)08714729973911(17)271021(10)35106439
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/05/2026

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 Model Number: H74939347070470
• Device Catalogue Number: H74939347070470
• Device Lot Number: 0035106439
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 12/10/2025; 01/04/2026
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/09/2025; 12/19/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 63 KG