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

Model Number	112266-001
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that removal difficulty occurred with the device.A 2.4mm jetstream? xc device was selected for a popliteal angiogram to treat a superficial femoral artery (sfa) thrombus occlusion.During the procedure, several passes were made with jetstream without issue.When removing the jetstream device, difficulty was encountered when removing it over the wire.The device was fully removed from the guidewire, and another attempt was made to put the jetstream back on the guidewire and into the patient.The device could not be reloaded onto the guidewire beyond 1cm.The procedure was completed with a different device of the same model.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.B5 - describe event or problem: updated with additional information.C2/d10 - concomitant product/therapy: updated with additional information.
Event or Problem Description
It was reported that removal difficulty occurred with the device.A 2.4mm jetstream xc device was selected for a popliteal angiogram to treat a superficial femoral artery (sfa) thrombus occlusion.During the procedure, several passes were made with jetstream without issue.When removing the jetstream device, difficulty was encountered when removing it over the wire.The device was fully removed from the guidewire, and another attempt was made to put the jetstream back on the guidewire and into the patient.The device could not be reloaded onto the guidewire beyond 1cm.The procedure was completed with a different device of the same model.There were no patient complications as a result of this event.It was further reported that a boston scientific thruway guidewire was the guidewire involved in this event.In addition, the 100% stenosed target lesion was severely calcified, and moderately tortuous.

• 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 LIMITED; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24707061
• Report Number: 2124215-2026-16756
• Device Sequence Number: 10467701
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2026

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: 112266-001
• Device Catalogue Number: 112266-001
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026; 05/20/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/23/2026; 06/15/2026
• 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: BOSTON SCIENTIFIC THRUWAY GUIDEWIRE
• Patient Sex: Unknown