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

Model Number	H74939347070470
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details and device status regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the balloon became stuck with the guidewire.A 7.0 mm x 40 mm x 75 cm athletis balloon catheter was advanced for dilatation of an avf stenosis.During positioning, the balloon became stuck on the guidewire and could not be advanced into the lesion.After several attempts, the device was determined to be defective.It was removed, and the procedure was completed with another of same device.No additional information was reported.
Event or Problem Description
It was reported that the balloon became stuck with the guidewire.A 7.0 mm x 40 mm x 75 cm athletis balloon catheter was advanced for dilatation of an avf stenosis.During positioning, the balloon became stuck on the guidewire and could not be advanced into the lesion.After several attempts, the device was determined to be defective.It was removed, and the procedure was completed with another of same device.No additional information was reported.
Additional Manufacturer Narrative
Device eval by mfr: the device was received with no guidewire inserted in the device.During the product analysis the investigator was unable to advance a boston scientific 0.035 guidewire through the device due to a blockage approximately 455mm distal from the proximal end of the hub.The device was soaked in a water bath at a temperature of 37 degrees celsius before further attempts were made to advance the guidewire.The device was removed from the water bath, and the user was still unable to advance the guidewire through the device due to the blockage.The investigator dissected the shaft of the device and solidified blood was removed from the shaft.A visual examination identified that the balloon was tightly folded and was not subjected to positive pressure.No issues were identified with the balloon material.No issues were noted with the tip of the device.A visual and tactile examination found no issues with 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: 23861070
• Report Number: 2124215-2025-87812
• Device Sequence Number: 9623066
• Product Code: LIT
• UDI-Device Identifier: 08714729973911
• UDI-Public: (01)08714729973911(17)280424(10)36375386
• 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
• Report Date (Section B): 02/23/2026

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: 0036375386
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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
• Patient Age: 71 YR
• Patient Sex: Female