MAUDE Adverse Event Report: INSIGHTEC LTD. EXABLATE 4000; MR GUIDED FOCUSED ULTRASOUND SYSTEM

Model Number 4000

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

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Dysphasia (2195)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

The retrospective analysis has not indicated any technical failures of the system.Treatment parameters were in line with the typical range.The system performance was found to be according to spec and as expected.No new risk has been recognized.No misalignment or smearing were seen on thermal images during the treatment and no heating outside the targeted area.Lesion is in the vim in the thalamus, as expected.Location of the middle cerebral artery (mca) stroke caused damage in the left temporal lobe, which is outside the targeted area and explains the symptoms that are known for stroke in this location.Cardiac evaluation post stroke demonstrated aortic stenosis and new onset atrial flutter, both significant stroke risk factors.According to the information for prescribers (pub41002923 ver.11) the following contraindications are listed: "patients with unstable cardiac status or severe hypertension".

Event Description

Patient was treated using focused ultrasound for essential tremor on the left side to treat the right hand tremor on (b)(6) 2024.The patient was discharged 3 hours after treatment with no neurolgoical deficits and was prescribed decadron.The next morning, we was found on the side of his bed and had right sided weakness and unable to speak.Emergency services transferred him to the hospital where he received fus treatment on (b)(6) 2024 the patient was diagnosed with dysphasia, mild legarthy, global aphasia, and was confirmed to have suffered a left mca stroke.Cardiac evaluation post stroke demonstrated aortic stenosis and new onset atrial flutter, both significant stroke risk factors.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC LTD.; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: may zimmerman ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 19056928
• MDR Text Key: 339552610
• Report Number: 9615058-2024-00012
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2024

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: 4000
• Device Catalogue Number: SYS943503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male