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

Model Number	45006
Medical Device Problem Codes	Failure to Advance (2524); Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device fractured.This 1.6mm jetstream sc catheter was selected for use in a bypass restenosis procedure.The moderate to severely tortuous lesion was located in the distal superficial femoral artery proximal popliteal bypass.Using an 014 thruway guidewire, treatment with this jetstream catheter was started; however, a kink was noted in the catheter and guidewire when attempting to advance.It was noted that the catheter was not stuck on anything.The catheter was removed and the guidewire inside was kinked and unusable.The catheter was not damaged; therefore, angioplasty was performed, and the jetstream catheter was attempted again with a new guidewire.It was working appropriately; however, then the catheter would not advance and was kinking up on itself.The catheter was removed intact, and multiple kinks were noted throughout.Additionally, a fracture was observed in the middle of the catheter.The procedure was successfully completed and there were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, visual examination of this jetstream atherectomy catheter revealed multiple bucklings to the sheath.Microscopic examination revealed no additional damages.A device-to-device interaction test was performed, and a test guidewire was able to pass through without any resistance.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that could have contributed to the failure to advance to lesion.
Event or Problem Description
It was reported that the device fractured.This 1.6mm jetstream sc catheter was selected for use in a bypass restenosis procedure.The moderate to severely tortuous lesion was located in the distal superficial femoral artery proximal popliteal bypass.Using an 014 thruway guidewire, treatment with this jetstream catheter was started; however, a kink was noted in the catheter and guidewire when attempting to advance.It was noted that the catheter was not stuck on anything.The catheter was removed and the guidewire inside was kinked and unusable.The catheter was not damaged; therefore, angioplasty was performed, and the jetstream catheter was attempted again with a new guidewire.It was working appropriately; however, then the catheter would not advance and was kinking up on itself.The catheter was removed intact, and multiple kinks were noted throughout.Additionally, a fracture was observed in the middle of the catheter.The procedure was successfully completed and there were no patient complications.

• 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: 20421664
• Report Number: 2124215-2024-63450
• Device Sequence Number: 8257705
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/30/2024

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: 02/07/2026
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0033156149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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: 014 THRUWAY GUIDEWIRE.; 014 THRUWAY GUIDEWIRE.
• Patient Sex: Male