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

Model Number	112264-001
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the infusion line ruptured and became stuck on the wire.A 2.1mm jetstream xc catheter was selected to treat target lesions in the patient's superficial femoral artery (sfa).During the procedure, the infusion line ruptured/separated, and the catheter became stuck on the non-boston scientific guidewire.The device leaked fluid from the break approximately 8-10 centimeters above the tip of the device.No patient complications occurred.
Event or Problem Description
It was reported that the infusion line ruptured and became stuck on the wire.A 2.1mm jetstream xc catheter was selected to treat target lesions in the patient's superficial femoral artery (sfa).During the procedure, the infusion line ruptured/separated, and the catheter became stuck on the non-boston scientific guidewire.The device leaked fluid from the break approximately 8-10 centimeters above the tip of the device.No patient complications occurred.It was further reported that the target lesions being treated were severely calcified in the patient's popliteal artery connecting to the superficial femoral artery (sfa).The device broke during removal from the patient, and fluid leaked out of the device which did not include blood.

• 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: 21449617
• Report Number: 2124215-2025-10961
• Device Sequence Number: 7158804
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Expiration Date: 09/22/2025
• Device Model Number: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0032279411
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/31/2025
• Date Device Manufactured: 08/23/2023
• 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: 0.014" COMMAND; 0.014" COMMAND
• Patient Sex: Unknown