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

Model Number 45006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 09/14/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 327994625
• Report Number: 2124215-2023-62507
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 43 KG