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 Problem Ischemia Stroke (4418)

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

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.Based on the medical history of this patient and the treating physician feedback, we assume that this event occurred due to the cessation of anticoagulants in a patient with paroxysmal atrial fibrillation, a known risk factor for ischemic stroke.According to the information for prescribers, patients with a history of abnormal bleeding, hemorrhage and/or coagulopathy is a contraindication for treatment.

Event Description

Patient was treated using focused ultrasound for essential tremor and had near compelte tremor relief.After the treatment was completed, a routine mri post-imaging scan was performed and the imaging showed a lesion compatible with ischemic stroke in the border of the putamen.Patient was asymptomatic and was admitted to the hospital for follow up and observation.As of dec 18th, the patient was reported to still be doing well with no additional symptoms related to the stroke.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nahum heth street; 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: 18525595
• MDR Text Key: 333030354
• Report Number: 9615058-2024-00001
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461021
• UDI-Public: 010729001546102112109022140101
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

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: SYS940350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization