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

Model Number	112266-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a distal embolism occurred that required additional intervention.The 100% stenosed, moderately tortuous, and severely calcified vessel was located in the distal superficial femoral artery (sfa).A jetstream? sc and jetstream xc catheters were selected for use in an endovascular therapy (evt) procedure to treat lower extremity arterial disease (lead).During the procedure, both of the devices functioned as expected.The patient experienced a distal embolism that required additional intervention.The additional intervention included embolization in the arterial tibial artery (ata) and aspiration to remove the debris.The debris was successfully retrieved, and the procedure was completed with the original device.
Event or Problem Description
It was reported a distal embolism occurred that required additional intervention.The 100% stenosed, moderately tortuous, and severely calcified vessel was located in the distal superficial femoral artery (sfa).Two jetstream? sc catheters were selected for use in an endovascular therapy (evt) procedure to treat lower extremity arterial disease (lead).During the procedure, both of the devices functioned as expected.The patient experienced a distal embolism that required additional intervention.The additional intervention included embolization in the arterial tibial artery (ata) and aspiration to remove the debris.The debris was successfully retrieved, and the procedure was completed with the original device.
Additional Manufacturer Narrative
D4 - lot number: updated with additional information received through the good faith effort process.Investigation results: the complaint device was not received at the complaint investigation site (cis) for analysis.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 'known inherent risk of device'.

• 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: 24834513
• Report Number: 2124215-2026-19385
• Device Sequence Number: 10306344
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: (01)08714729889861(17)270309(10)35797459
• 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): 05/08/2026

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 Model Number: 112266-001
• Device Catalogue Number: 112266-001
• Device Lot Number: 0037587080
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: JETSTREAM? SC; JETSTREAM? SC; PARENT 60 PRO INTRODUCER SHEATH; PARENT 60 PRO INTRODUCER SHEATH; THRUWAY GUIDEWIRE; THRUWAY GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown