MAUDE Adverse Event Report: INSIGHTEC, LTD. EXABLATE NEURO FOCUSED ULTRASOUND; MR-GUIDED FOCUSED ULTRASOUND SYSTEM

Model Number 4000

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

Patient Problems Death (1802); Pneumonia (2011); Sepsis (2067)

Event Date 09/17/2020

Event Type  Death  

Event Description

The pt initial presented with right facial pain who was diagnosed in 2013 with stage 4b squamous cell carcinoma of the right tonsil/tongue.This pt enrolled in a clinical trial ((b)(6)) on (b)(6) 2020 for head and neck cancer pain and was subsequently treated with focused ultrasound on (b)(6) 2020 without any unexpected issues/adverse events, on (b)(6) 2020 the patient was admitted to an outside healthcare facility with severe e.Coli sepsis in the setting of lobar pneumonia.The patient expired the following morning on (b)(6) 2020, the pl deemed this event unrelated to the focused ultrasound procedure.

• Brand Name: EXABLATE NEURO FOCUSED ULTRASOUND
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC, LTD. ; dallas TX
• MDR Report Key: 10605698
• MDR Text Key: 209378910
• Report Number: MW5096937
• Device Sequence Number: 1
• Product Code: POH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 63 YR
• Patient Weight: 61