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

Model Number	112264-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a distal embolism occurred, requiring an additional device.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.A jetstream xc atherectomy catheter was selected for the endovascular therapy procedure to treat arteriosclerosis obliterans.The jetstream catheter was prepared according to the instructions for use.After crossing with a wire via a contralateral approach, the wire was exchanged for another non-boston scientific filter wire.Atherectomy was then performed using the jetstream xc atherectomy catheter, first with the 2.1-mm size, followed by blade-up atherectomy with the 3.0-mm size.The filter used was moving up and down significantly inside the blood vessel while jetstream catheter was in operation, which may have caused biomaterial to leak from the filter.Distal embolization was observed on angiography thereafter.The occluded vessel was aspirated using a mach1 st catheter, followed by dilation with a 1.5 mm x 40 mm balloon.Blood flow in the embolized vessel was successfully restored to its original state.There were no further complications.One day later, it was noted that there had been no change in the patient condition.

• 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: 24344784
• Report Number: 2124215-2026-08487
• Device Sequence Number: 9836688
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: (01)08714729889892(17)271117(10)37725458
• 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): 02/16/2026

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: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0037725458
• 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: 01/19/2026
• Initial Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 10/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown