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

Model Number	112262-001
Medical Device Problem Codes	Suction Problem (2170); Noise, Audible (3273); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city:(b)(6).
Event or Problem Description
It was reported that failure to evacuate occurred.The 75% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery (sfa).A 1.85mm jetstream sc catheter was selected for an endovascular thrombectomy (evt) procedure to treat peripheral artery disease (pad).During the procedure, a noise was heard, and loss of aspiration occurred.After, priming was performed but not could not be completed successfully.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
E1 - initial reporter city: (b)(6).Device evaluation by manufacturer: the returned product to boston scientific consisted of a jetstream sc catheter, 1.85mm, us.The device was visually and microscopically examined for any shaft damage.The devices catheter shaft showed no damage.The device was set-up and functionally tested per the ifu.The device was connected to the test console and the device primed and ran as designed.The set up was repeated multiple times with no issues.The device was tested for a period of 1 minute with no alarms or errors.Inspection of the remainder of the device revealed no damage or irregularities.
Event or Problem Description
It was reported that failure to evacuate occurred.The 75% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery (sfa).A 1.85mm jetstream sc catheter was selected for an endovascular thrombectomy (evt) procedure to treat peripheral artery disease (pad).During the procedure, a noise was heard, and loss of aspiration occurred.After, priming was performed but not could not be completed successfully.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: 23496823
• Report Number: 2124215-2025-80743
• Device Sequence Number: 15679608
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: (01)08714729889861(17)270622(10)36587002
• 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,Followup
• Report Date (Section B): 12/05/2025

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: 0036587002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown