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

Model Number	112264-001
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that aspiration failure occurred.A 2.1mm jetstream xc catheter was selected for a leg angiogram to treat peripheral artery disease.The jetstream xc catheter was prepped in routine fashion.While treating the stenosis, bubbles were noticeable in the aspiration tubing, and the device stopped aspirating.The catheter was taken out of the body and re-primed.The issue persisted so a new catheter was used to complete the procedure.There were no patient complications as a result of this 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; 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: 24270473
• Report Number: 2124215-2026-05303
• Device Sequence Number: 10658696
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: (01)08714729889892(17)271213(10)37935430
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/05/2026

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: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0037935430
• 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: 01/07/2026
• Initial Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 11/12/2025
• 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
• Patient Sex: Unknown