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

Model Number	112266-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
Event or Problem Description
It was reported the device became stuck on the guidewire and was difficult to remove.The 100% stenosed, severely calcified target area was located in the superficial femoral artery (sfa).A 2.4 mm jetstream? xc catheter was selected for an endovascular thrombectomy (evt) procedure in the sfa to treat lower extremity artery stenosis.During the procedure the jetstream? xc catheter became stuck on a non-boston scientific filter wire guidewire and the jetstream? xc catheter was difficult to remove from inside of the patient.The jetstream? xc catheter and non-boston scientific filter wire guidewire had to be removed together as one unit.The non-boston scientific filter wire guidewire could not be removed from the jetstream? xc catheter when outside of the patient.Another device of a different 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).Investigation results: inspection of the returned jetstream revealed no damage.The complaint was confirmed as the device was stuck on a filter guidewire.Device analysis: the returned device is a jetstream atherectomy catheter with a filter guidewire stuck inside.The device was visually and microscopically examined for any damage.Visual examination and microscopic examination revealed no damage.Inspection of the remainder of the device revealed no damage or irregularities.Product analysis confirmed the device is stuck on a guidewire.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 'failure to follow instructions.'.
Event or Problem Description
It was reported the device became stuck on the guidewire and was difficult to remove.The 100% stenosed, severely calcified target area was located in the superficial femoral artery (sfa).A 2.4 mm jetstream? xc catheter was selected for an endovascular thrombectomy (evt) procedure in the sfa to treat lower extremity artery stenosis.During the procedure the jetstream? xc catheter became stuck on a non-boston scientific filter wire guidewire and the jetstream? xc catheter was difficult to remove from inside of the patient.The jetstream? xc catheter and non-boston scientific filter wire guidewire had to be removed together as one unit.The non-boston scientific filter wire guidewire could not be removed from the jetstream? xc catheter when outside of the patient.Another device of a different model was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 24447603
• Report Number: 2124215-2026-10411
• Device Sequence Number: 10307926
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)271011(10)37416239
• 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): 04/24/2026

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: 0037416239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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: NIPRO FILTERWIRE GUIDEWIRE.; NIPRO FILTERWIRE GUIDEWIRE.
• Patient Sex: Unknown