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 superficial vein of the forearm (vena cephalica antebrachii).A 7.0 mm x 40 mm x 75 cm athletis balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured on the second inflation at 32 atmospheres for 30 seconds.The procedure was completed using with another of the same device.There were no patient complications as a result of tis event.
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the superficial vein of the forearm.A 7.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured while being inflated to 32 atmospheres.The procedure was completed using with another of the same device.There were no patient complications as a result of tis 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 revealed that the balloon was not folded, indicating that it had been exposed to positive pressure.The rated burst pressure for this device is 34 atmospheres per athletis specifications.The returned device was connected to an encore inflation unit, and positive pressure was applied, at which time liquid leakage was observed from a pinhole in the balloon located approximately 22 mm distal to the proximal marker band.Visual and tactile inspection identified 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 stenosed target lesion was located in the superficial vein of the forearm.A 7.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured while being inflated to 32 atmospheres.The procedure was completed using with another of the same device.There were no patient complications as a result of tis event.It was further reported that there were two devices used in the same one procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the superficial vein of the forearm.A 7.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured while being inflated to 32 atmospheres.The procedure was completed using with another of the same device.There were no patient complications as a result of tis 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.
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6).E1 - initial reporter phone: (b)(6).The device was returned for analysis.Visual examination revealed that the balloon was not folded, indicating that it had been exposed to positive pressure.The rated burst pressure for this device is 34 atmospheres per athletis specifications.The returned device was connected to an encore inflation unit, and positive pressure was applied, at which time liquid leakage was observed from a pinhole in the balloon located approximately 22 mm distal to the proximal marker band.Visual and tactile inspection identified 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: 22971176
• Report Number: 2124215-2025-60308
• Device Sequence Number: 13042704
• Product Code: LIT
• UDI-Device Identifier: 08714729973911
• UDI-Public: (01)08714729973911(17)271009(10)35030909
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,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: 0035030909
• 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; 12/23/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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