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

Model Number	112260-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jetstream became stuck to the thruway guidewire.A jetstream 1.6 sc atherectomy catheter was selected for percutaneous transluminal angioplasty treatment from the right common femoral artery to the superficial femoral artery.The procedure was done at a crossover, and the cia bifurcation was steep.The lesion was reported as 100 percent stenosed with severe calcification and tortuosity.During the procedure, the lesion part was ablated; however, during attempt to remove the jetstream catheter it was stuck with the thruway guidewire.The surgeon removed the whole system together, and the thruway and jetstream were able to be unstuck outside the body causing the thruway to become deformed.The procedure was completed with an another of the same device without sequelae.
Event or Problem Description
It was reported that the jetstream became stuck to the thruway guidewire.A jetstream 1.6 sc atherectomy catheter was selected for percutaneous transluminal angioplasty treatment from the right common femoral artery to the superficial femoral artery.The procedure was done at a crossover, and the cia bifurcation was steep.The lesion was reported as 100 percent stenosed with severe calcification and tortuosity.During the procedure, the lesion part was ablated; however, during attempt to remove the jetstream catheter it was stuck with the thruway guidewire.The surgeon removed the whole system together, and the thruway and jetstream were able to be unstuck outside the body causing the thruway to become deformed.The procedure was completed with an another of the same device without sequelae.Additional information provided device lot number.

• Brand Name: JETSTREAM SC
• 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: 20675882
• Report Number: 2124215-2024-71385
• Device Sequence Number: 15529815
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• 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): 12/04/2024

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: 09/20/2025
• Device Model Number: 112260-001
• Device Catalogue Number: 112260-001
• Device Lot Number: 0032255501
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THRUWAY GUIDEWIRE.; THRUWAY GUIDEWIRE.
• Patient Sex: Unknown