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

Model Number	112262-001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Noise, Audible (3273); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) reported here as the facility name exceeded character limit for designated field.
Event or Problem Description
It was reported that a loss of aspiration occurred.The target lesion in the superficial femoral artery (sfa) was 95% stenosed, severely calcified and moderately tortuous.A 1.85mm jetstream sc atherectomy catheter was selected for use.During the procedure, there was no suction inside the patient, only air returned.Liquid was observed to be leaking from the control pod.The control pod also made a high-pitch noise when rotating.The device was replaced with a new device, same model to complete the procedure.There were no patient complications as a result of the 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: 23728520
• Report Number: 2124215-2025-86081
• Device Sequence Number: 10216268
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: (01)08714729889861(17)270622(10)36587003
• 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): 12/05/2025

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: 0036587003
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/05/2025
• 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
• Patient Sex: Unknown