MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM? XC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	112266-001
Medical Device Problem Codes	Entrapment of Device (1212); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device became stuck on a guidewire.A 2.4 mm jetstream xc catheter was selected for a leg angiogram procedure to treat claudication.During the procedure the device became stuck on a non-boston scientific guidewire.Both the 2.4 mm jetstream xc catheter and non-boston scientific guidewire had to be removed from inside of the patient as one unit.When the 2.4 mm jetstream xc catheter was separated from the non-boston scientific guidewire, the device stopped working as expected.A new device was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: JETSTREAM? XC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23850802
• Report Number: 2124215-2025-92024
• Device Sequence Number: 9543663
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)271005(10)37370663
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 112266-001
• Device Catalogue Number: 112266-001
• Device Lot Number: 0037370663
• 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: 12/02/2025
• Initial Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 09/04/2025
• 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: MEDTRONIC SPIDERFX GUIDEWIRE
• Patient Sex: Unknown