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

Model Number	112266-001
Medical Device Problem Codes	Entrapment of Device (1212); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device became kinked and stuck on the guidewire.The mildly calcified and moderately tortuous target area was located in the superficial femoral artery (sfa).A jetstream xc device was selected for an atherectomy procedure in the sfa to treat the target occlusion.During the procedure the jetstream xc became kinked, distal to the infusion port on the device, when attempting to pass through a bifurcation.Then, the device became stuck on a non-boston scientific guidewire.The jetstream xc and non-boston scientific guidewire had to be removed together as one unit.A different device with a new guidewire was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.Device analysis findings: the returned product that was received by boston scientific consisted of a jetstream atherectomy catheter.Visual and microscopic inspection was completed.Visual examination revealed multiple kinks.Microscopic examination revealed no additional damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a kink on the sheath.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported the device became kinked and stuck on the guidewire.The mildly calcified and moderately tortuous target area was located in the superficial femoral artery (sfa).A jetstream xc device was selected for an atherectomy procedure in the sfa to treat the target occlusion.During the procedure the jetstream xc became kinked, distal to the infusion port on the device, when attempting to pass through a bifurcation.Then, the device became stuck on a non-boston scientific guidewire.The jetstream xc and non-boston scientific guidewire had to be removed together as one unit.A different device with a new guidewire was used to complete the procedure.There were no patient complications as a result of this event.It was further reported that a different jetstream xc of the same model was used to complete the procedure.

• 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24506581
• Report Number: 2124215-2026-11948
• Device Sequence Number: 13410055
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)271213(10)37936097
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 04/03/2026

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
• Device Lot Number: 0037936097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• 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: 014 ASHAHI GLIDE ADVANTAGE GUIDEWIRE; 014 ASHAHI GLIDE ADVANTAGE GUIDEWIRE
• Patient Sex: Male
• Patient Race: White