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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  Death  

Manufacturer Narrative

The retrospective analysis has not indicated any technical failures or erroneous operation of the system.The treatment was planned and executed in accordance with treatment guidelines and labeling.It appears that treatment parameters were within normal range for this type of treatment.According to the treating site team, the death is most likely not related to the treatment but since autopsy will not be conducted (per family choice), the certainty is limited.According to this treatment review, we see no evidence of failure, malfunction, improper or inadequate design, manufacture, labeling or user error resulting in the adverse event.

Event Description

According to information from the treating physicians: patient, (b)(6) years old previously diagnosed with copd underwent essential tremor treatment.The treatment ended successfully with good tremor control and no adverse events reported post procedure.After the treatment and as part of the routine hospital's procedure, the patient was held for observation until later in the evening after the procedure.He was dismissed from the hospital that evening.The following day he was feeling well and satisfied with the tremor reduction.In the evening, the patient unexpectedly died while eating dinner.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC LTD; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: meital trank ; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 11761853
• MDR Text Key: 248580582
• Report Number: 9615058-2021-00010
• 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: 05/03/2021

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: SYS940352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR