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

Model Number	45006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed distal embolization of the peroneal artery.This 1.6mm jetstream sc catheter was selected for use in a superficial femoral artery (sfa) and proximal popliteal artery atherectomy procedure.Distal embolization of the peroneal artery was observed after cutting was performed with this device.A percutaneous intervention was performed approximately one week later, and the patient outcome was considered resolved.
Event or Problem Description
It was reported that the patient developed distal embolization of the peroneal artery.This 1.6mm jetstream sc catheter was selected for use in a superficial femoral artery (sfa) and proximal popliteal artery atherectomy procedure.Distal embolization of the peroneal artery was observed after cutting was performed with this device.A percutaneous intervention was performed approximately one week later, and the patient outcome was considered resolved.
Event or Problem Description
It was reported that the patient developed distal embolization of the peroneal artery.This 1.6mm jetstream sc catheter was selected for use in a superficial femoral artery (sfa) and proximal popliteal artery atherectomy procedure.Distal embolization of the peroneal artery was observed after cutting was performed with this device.A percutaneous intervention was performed approximately one week later, and the patient outcome was considered resolved.
Additional Manufacturer Narrative
Sending correction report for updated h6: impact code.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 no problem detected.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 16640517
• Report Number: 2124215-2023-12312
• Device Sequence Number: 20171615
• Product Code: MCW
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K133023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2024
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0029584958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 06/25/2026
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/14/2023; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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: 89 YR
• Patient Sex: Male
• Patient Weight: 123 LB