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

Model Number	112262-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device became stuck on a non-boston scientific guidewire.A 1.85mm jetstream sc catheter was selected for a procedure to treat a 90% stenosed, moderately tortuous, and severely calcified target region with intermittent claudication located in the superficial femoral artery (sfa).After the 1.85mm jetstream sc catheter was used in combination with a non-boston scientific guidewire, the 1.85mm jetstream sc catheter became stuck on the non-boston scientific guidewire.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? SC
• 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: 23304190
• Report Number: 2124215-2025-73418
• Device Sequence Number: 18636951
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: (01)08714729889861(17)270622(10)36587001
• 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
• Report Date (Section B): 10/15/2025

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: 112262-001
• Device Catalogue Number: 112262-001
• Device Lot Number: 0036587001
• 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: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 05/22/2025
• 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: NIPRO 8MM FILTRAP.
• Patient Sex: Unknown