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

Model Number	45006
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date estimated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported during an academic conference that filter wire entrapment occurred.As a result, an obstruction occurred, requiring medical intervention.The jetstream sc atherectomy catheter was selected for an endovascular therapy (evt) procedure in a target lesion that extended from the left superficial femoral artery (sfa) to the popliteal p1.The target lesion was 90% stenosed with moderate tortuosity and severe calcification.The jetstream was used in conjunction with a non-boston scientific (bsc) filter wire.After completing the cutting with jetstream, the filter wire and jetstream were stuck when it was attempted to be removed with rex.The jetstream and filter wire were being removed together, but the filter part of the filter wire got caught in the front portion of the lesion that was not treated by jetstream.The collected material inside the filter was squeezed out of the filter part.This caused the peroneal portion of one below-the-knee (btk) runoff to become obstructed.After additional treatment, the flow improved, and the procedure was completed.The next day, both the sfa and bk were re-occluded, so evt was performed again.A non-bsc stent was implanted in the sfa, and a non-bsc stent graft system was implanted in the bk peroneal, and the procedure was completed.Later, in the middle of the night, they were re-occluded (this re-occlusion originated from the occlusion of the stent graft system), and the patient died due to reperfusion failure.Although this occurred in a case where jetstream was used, the physician believes that it was not the fault of the device.The patient background was poor to begin with, and the patient was brought in near to acute limb ischemia (ali) during the first procedure, and the second procedure also resulted in ali, so it was a case of high urgency.Therefore, it was not the device that caused the death, but the poor preoperative background of the patient and poor postoperative ali management that led to their death.

• 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 LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19955201
• Report Number: 2124215-2024-47958
• Device Sequence Number: 21028760
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• 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): 08/09/2024

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: 45006
• Device Catalogue Number: 45006
• 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: 07/12/2024
• Initial Report FDA Received Date: 08/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male