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

Model Number	H74939347050470
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	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter entrapment occurred.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified radio cephalic aarteriovenous fistula (avf).A 5.0mm x 40mm x 75cm athletis balloon catheter was selected for use.During the procedure, it was noted that the catheter became stuck with a non-boston scientific (non-bsc) guidewire and does not move.The guide wire and balloon were removed simultaneously without any additional intervention.The procedure was completed with another of same device.The patient recovered without any ill effects.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a catheter entrapment occurred.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified radio cephalic arteriovenous fistula (avf).A 5.0mm x 40mm x 75cm athletis balloon catheter was selected for use.During the procedure, it was noted that the catheter became stuck with a non-boston scientific (non-bsc) guidewire and does not move.The guide wire and balloon were removed simultaneously without any additional intervention.The procedure was completed with another of same device.The patient recovered without any ill effects.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr: the athletis device was returned for analysis.A visual and tactile examination identified multiple shaft kinks and damage noted along the length of the device.The shaft was also noted to be stretched.This athletis device is recommended for use with a 0.035" guidewire as per athletis instructions for use.The device was returned with the customer's guidewire inserted in the device.The investigator was unable to remove the guidewire due to the damage noted to the shaft.A visual examination identified that the balloon was subjected to positive pressure.No issues were identified with the balloon material.No issues were noted with the tip of the device.No other issues were identified with 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: 23497792
• Report Number: 2124215-2025-80826
• Device Sequence Number: 21110961
• Product Code: LIT
• UDI-Device Identifier: 08714729973676
• UDI-Public: (01)08714729973676(17)270319(10)33658463
• 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): 12/19/2025

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: H74939347050470
• Device Catalogue Number: H74939347050470
• Device Lot Number: 0033658463
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: 54 YR
• Patient Sex: Unknown