BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISUAL-ICE® CRYOABLATION SYSTEM

    MDR report key: 6798654 · Received August 16, 2017

    Report

    Report Number
    3004462490-2017-00005
    Event Type
    Death
    Date Received
    August 16, 2017
    Date of Event
    April 6, 2017
    Report Date
    August 16, 2017
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLES AND SYSTEM WERE NOT RETURNED TO GALIL FOR PHYSICAL INVESTIGATION. THE NEEDLE'S LOT NUMBER WAS NOT PROVIDED AND THEREFORE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THERE WERE 20 ICEROD PLUS 90° NEEDLES SHIPPED TO THE CUSTOMER. THERE WERE NO NON-CONFORMANCE OBSERVED RELATED TO THE REPORTED COMPLAINT. PER CORRESPONDENCE WITH THE CUSTOMER, THERE WAS NO ADDITIONAL INFORMATION REGARDING THIS EVENT. GALIL MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION, BUT RECEIVED NO RESPONSE AND, THEREFORE, WAS UNABLE TO DETERMINE IF THE CAUSE OF THE EVENT WAS RELATED TO THE CRYOABLATION DEVICE OR PROCEDURE. THERE WERE NO REPORTS OF ALLEGED DEVICE MALFUNCTION. GALIL HAS NOT PREVIOUSLY RECEIVED REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    FDA FORWARDED AN USER FACILITY MEDWATCH REPORT WHICH STATED THAT THE PATIENT PRESENTED WITH A RENAL MASS AND HAD A LAPAROSCOPIC RENAL CRYOABLATION. THE PATIENT WAS INITIALLY EXTUBATED POST PROCEDURE. HOWEVER, THE PATIENT REMAINED UNRESPONSIVE AND REQUIRED RE-INTUBATION. THE PATIENT WAS TRANSPORTED TO SICU WHERE HE DEVELOPED MYOCLONIC STATUS EPILEPTICS AND WENT INTO A COMA. THE PATIENT WAS PLACED ON COMFORT MEASURE AND CEASED TO BREATHE ON (B)(6) 2017. GALIL CONTACTED THE CUSTOMER FOR ADDITIONAL INFORMATION. THE CUSTOMER REPORTED THAT 3 EACH FPRPR3508 ICE ROD PLUS CRYONEEDLES WERE USED AND THERE WAS NOTHING REMARKABLE TO REPORT ABOUT THE CASE. THE CUSTOMER DID NOT REPORT ANY DEVICE MALFUNCTIONS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579006 VISUAL-ICE® CRYOABLATION SYSTEM CRYOSURGICAL DEVICES AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O