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 Hemorrhagic Stroke (4417)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

The event happened before the treatment started and after placing the head frame for the treatment.The event is not related to the treatment and system but it may be procedure related.

Event Description

Prior to treatment, while the patient wearing the headframe and, on the table, they became limp on the right side and unresponsive.Patient was diagnosed with a hemorrhagic stroke.Patient underwent urgent craniotomy the afternoon after the event to remove the hemorrhage and resect the arteriovenous blood vessel malformation (avm).

• 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: 18667024
• MDR Text Key: 334845139
• Report Number: 9615058-2024-00003
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2024

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: SYS942503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability; Hospitalization