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	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 90% stenosed target lesion was located in a moderately tortuous superficial femoral artery.Severe calcification was also noted from the mid to distal part of the superficial femoral artery.A 2.4mm jetstream xc catheter was selected for an endovascular therapy procedure.After performing complete ablation with a jetstream sc atherectomy catheter, the catheter was replaced with the 2.4mm jetstream xc catheter.While performing ablation from the proximal to mid and distal superficial femoral artery, it suddenly got stuck with non-boston scientific filter wire and could not be advanced.Both the filter wire and jetstream catheter were removed together.The guidewire was replaced with thruway 0.014 300cm, and the procedure was continued using a new jetstream catheter of the same size; the procedure was then successfully completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: 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 damages.Inspection of the remainder of the device revealed no damage or irregularities.Product analysis confirmed the device is stuck on a guidewire.Device history 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 that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Investigation conclusion: boston scientific concludes the most probable root cause as failure to follow instructions.It was reported that the jetstream catheter became entrapped on a non-boston scientific filter wire.Device analysis confirmed the jetstream catheter was stuck on the filter wire.The filter wire is not one of the listed compatible guidewires according to the instructions for use, suggesting the root case was a failure to follow instructions.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24576396
• Report Number: 2124215-2026-13724
• Device Sequence Number: 13120331
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)271031(10)37586892
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: 0037586892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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