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

Model Number	H74939347051070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 5.0mm x 100mm x 75cm athletis balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure to treat shunt stenosis.The target area was 75% stenosed, and the anatomy was moderately tortuous.During the procedure, the balloon ruptured at 6 atmospheres when inflated for 10 seconds.A pinhole was located near the balloon tip.The device was removed using the normal method without issue, and the procedure was completed with a different device.There were no patient complications as a result of this event, and the patient was in good condition after the procedure.

• 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 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23639715
• Report Number: 2124215-2025-84590
• Device Sequence Number: 9444186
• Product Code: LIT
• UDI-Device Identifier: 08714729973737
• UDI-Public: (01)08714729973737(17)280120(10)35664430
• 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
• Report Date (Section B): 11/24/2025

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: H74939347051070
• Device Catalogue Number: H74939347051070
• Device Lot Number: 0035664430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/24/2025
• 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.; INFLATION DEVICE-VISTA.; INTRODUCER SHEATH-6FR.
• Patient Sex: Unknown