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

Model Number	112266-001
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.This 2.4mm jetstream xc catheter catheter was selected for use during an atherectomy procedure to treat a 100% occluded, mildly calcified superficial femoral artery lesion.During the procedure, a wire was placed across the lesion, then the jetstream catheter was unable to cross the lesion and became bogged down, then stalled out despite efforts to overcome this challenge.Wire access was lost during the removal of the jetstream and was not able to be reestablished.Therefore, the case was cancelled and rescheduled for another date, using alternative methods.The patient had received moderate sedation and local anesthetic for the procedure.There were no patient complications.It was noted that the catheter operated correctly and did not contribute to the event.

• 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24216073
• Report Number: 2124215-2026-05394
• Device Sequence Number: 9385453
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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
• 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: 01/06/2026
• Initial Report FDA Received Date: 01/29/2026
• 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