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

Model Number	45006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter zip code: (b)(6).
Event or Problem Description
It was reported that a vessel perforation occurred.The 100% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery (sfa).A 1.85mm jetstream sc catheter was selected for the endovascular therapy procedure to treat the peripheral artery disease.After passing the guidewire through, intravascular ultrasound was performed to check the characteristics of the lesion.During that time, a part of the guidewire passed through the tunica media of the blood vessel, and it was not noticed.It was thought that the jetstream that was operated at the same part cut through it, which led to the perforation of the blood vessel.In addition, contrast imaging for confirmation was performed after jetstream cutting leaving the chronic total occlusion (cto) distal cap.It is also possible that the intravascular pressure increased when flushing vigorously for the contrast imaging, which supported the perforation of the blood vessel.The jetstream was removed normally, and a non-boston scientific stent was placed in the perforated vessel.Complete hemostasis was confirmed, and bailout was performed to complete the procedure.There were no other complications reported.

• 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: 17484072
• Report Number: 2124215-2023-38360
• Device Sequence Number: 12598010
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2024
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0030558541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown