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	Pseudoaneurysm (2605)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pseudoaneurysm occurred.The target lesion was located in a severely calcified right superficial femoral artery (sfa).The lesion length was 50mm.The lesion was cut twice with a 1.85mm jetstream sc catheter and was cut once with a 2.4mm jetstream xc catheter during the index procedure on (b)(6) 2022.On (b)(6) 2023, lower extremity ultrasound showed no indication of pseudoaneurysm and no restenosis.At the outpatient clinic on (b)(6) 2023, restenosis of the right sfa was suspected by lower extremity artery ultrasound.A pseudoaneurysm was then diagnosed at angio when revascularization was performed on (b)(6) 2023.As a result, on (b)(6) 2023, pseudoaneurysm closure and endarterectomy were performed under general anesthesia.The adventitial structure was partially destroyed on the outside of the proximal part of the right sfa, and after resecting the same part, a patch of bovine pericardium was applied in the fan direction, and endarterectomy was performed centrally and peripherally, and a bovine pericardium patch was applied to the vascular calcification.Plastic surgery was performed using a bovine pericardial patch.Ivus at the time of the initial treatment showed cutting near the adventitia and a hematoma image in the surrounding area, so it was thought that excessive cutting during the initial treatment damaged the vascular wall and caused a pseudoaneurysm in the chronic phase.The patient's general condition was stable, and the patient was being followed up as an outpatient.The patient had a lymph node issue after surgery and was currently being treated.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18120766
• Report Number: 2124215-2023-62507
• Device Sequence Number: 17861304
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• 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
• Report Date (Section B): 11/13/2023

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 Model Number: 45006
• Device Catalogue Number: 45006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 84 YR
• Patient Sex: Female
• Patient Weight: 43 KG