FDA Adverse Event Injury Summary report: N

NEUROBLATE SYSTEM

MDR report key: 7533945 · Received May 21, 2018

Report

Report Number
MW5077370
Event Type
Injury
Date Received
May 21, 2018
Date of Event
April 20, 2018
Report Date
May 17, 2018
Manufacturer
MONTERIS MEDICAL CORP.
Product Code
GEX
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM A SPOUSE OF A PATIENT WHO UNDERWENT A NEUROBLATE PROCEDURE FOR ABLATION OF MENINGIOMA ON 04/20 AT (B)(6) WITH DR. (B)(6). THE PROCEDURE WAS EST. TO BE 7 HOURS. HOWEVER, IT ENDED UP NEARER TO 15 HOURS DUE TO MALFUNCTION OF THE NEUROBLATE LASER "FAILING TO FIRE". THIS WAS AFTER DR. (B)(6) TOLD ME THEY ALSO HAD ISSUES WITH MRI AND MAPPING. THE "SOLVE" THAT DR. (B)(6) PROPOSED WAS THAT, A "PART" FROM ANOTHER NEUROBLATE DEVICE AT A HOSPITAL IN (B)(6) WOULD BE REMOVED AND BROUGHT UP ON THE METRO NORTH TRAIN TO ATTEMPT A FIX AT A JOURNEY OF 3-4 HOURS. HOURS LATER, THE DEVICE FINALLY "FIRED" AND THE PROCEDURE WAS FINISHED. THE RESULTS LEFT MY WIFE WITH A DEFICIT WE DID NOT PLAN FOR AND SPOKE WITH DR. (B)(6) ABOUT AVOIDING WITH THIS PROCEDURE. SHE HAD MUCH MORE SEVERE LEFT SIDE WEAKNESS AND HAD TO DO A 2 WEEK STAY IN REHAB FACILITY THAT WAS NEVER DISCUSSED. IT WAS COMMUNICATED SHE WOULD BE HOME 2-3 DAYS AFTER SURGERY AT THE LATEST. DR. (B)(6) DID NOT INFORM US OF THE RECALL BEFORE THE PROCEDURE. SHE DID SAY THAT THE "REASON FOR THE RECALL WAS NOT THE REASON FOR THE PROBLEM". BUT, I THINK YOU AND YOUR TEAM MIGHT WANT TO FURTHER UNDERSTAND THE RELIABILITY, OR RATHER LACK THEREOF, WITH THE NEUROBLATE DEVICE. I BELIEVE WE SHOULD HAVE BEEN INFORMED OF RECALL AND WOULD HAVE DISCUSSED IF WE STILL WANTED TO PROCEED WITH THIS PROCEDURE. SHOULDN'T THERE BE BACK UP PARTS AT THE FACILITY FOR POTENTIAL ISSUES LIKE THIS? SEEMS BASIC. IF YOU WOULD LIKE TO KNOW MORE ABOUT THIS CASE PLEASE CONTACT ME. CONCERNED FOR OTHER NEUROBLATE DEVICE PATIENTS, (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
371565 NEUROBLATE SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP. NA TO PATIENT NA

Patients

Seq Age Sex Outcome Treatment
1 45 YR Hospitalization