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

Model Number	112264-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the guidewire became entrapped inside of the device.The moderately tortuous, 100% stenosed chronic total occlusion (cto) was located in the superficial femoral artery (sfa).A 2.1mm jetstream xc catheter was selected for an endovascular thrombectomy (evt) procedure to treat the cto.During the procedure, the 2.1mm jetstream xc catheter became stuck on a boston scientific rotawire.Both the boston scientific rotawire and 2.1mm jetstream xc catheter were removed together as one unit from inside of the patient.A different device of the same model was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5 - describe event or problem section corrected with unknown guidewire involved in the event.
Event or Problem Description
It was reported the guidewire became entrapped inside of the device.The moderately tortuous, 100% stenosed chronic total occlusion (cto) was located in the superficial femoral artery (sfa).A 2.1mm jetstream xc catheter was selected for an endovascular thrombectomy (evt) procedure to treat the cto.During the procedure, the 2.1mm jetstream xc catheter became stuck on an unknown guidewire.Both the unknown guidewire and 2.1mm jetstream xc catheter were removed together as one unit from inside of the patient.A different device of the same model 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: 23832596
• Report Number: 2124215-2025-91578
• Device Sequence Number: 9288271
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: (01)08714729889892(17)260314(10)33408647
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Expiration Date: 03/14/2026
• Device Model Number: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0033408647
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/18/2025
• Date Device Manufactured: 02/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC ROTAWIRE.
• Patient Sex: Unknown