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	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc as the account did not have the available information at the time the report was submitted.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.
Event or Problem Description
It was reported that guidewire entrapment occurred.The 99% stenosed target lesion was located in a severely calcified and non-tortuous superficial femoral artery.A 1.85mm jetstream sc catheter was selected for the atherectomy procedure to treat the lower extremity arterial disease.A same-side antegrade approach was used.A non-boston scientific (bsc) sheath was placed, and a tourniquet was applied at the knee.However, due to calcification, blood flow could not be occluded, so a non-bsc embolic protection device was used.When the jetstream was used for cutting and then withdrawn, the non-bsc embolic protection device and the jetstream became entrapped and could not be removed.While traction was applied, the filter portion of the non-bsc embolic protection device became separated.After the jetstream was removed, the separated portion was safely retrieved with an intravascular forceps.The procedure was completed without issues, and the physician reported that the patient's condition is stable.

• 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; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23747897
• Report Number: 2124215-2025-89638
• Device Sequence Number: 9428719
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: (01)08714729889861
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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
• 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: 11/12/2025
• Initial Report FDA Received Date: 12/08/2025
• 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: FILTRAP EMBOLIC PROTECTION DEVICE
• Patient Sex: Unknown