BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING INSERTION TUBE

    MDR report key: 6666541 · Received June 26, 2017

    Report

    Report Number
    3002250546-2017-00004
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 23, 2017
    Manufacturer
    FHC, INC
    Product Code
    HAW
    PMA / PMN Number
    K011992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS NOT BEEN RETURNED YET.

    Additional Manufacturer Narrative · 0

    THE SURGEON INVOLVED IN THIS EVENT HAD INSERTED THE LEAD AND THEN REMOVED THE LEAD AND RE-INSERTED THE STYLET WITHOUT THE STOP TUBE IN PLACE. AS A RESULT, THE TIP OF THE STYLET WAS POSITIONED 12.7 MM DEEPER, WHICH IS THE LENGTH OF THE STOP TUBE COLLAR. SURGEON THEN REMOVED THE STYLET AND REPLACED THE LEAD. FROM THE SURGEON'S NARRATIVE IT WAS CONCLUDED THAT THE EVENT OCCURRED DUE TO MISHANDLING OF THE PRODUCT. AS A CORRECTIVE ACTION, THE SURGEON WAS TRAINED ON HANDLING THE DEVICE AND DFU (DIRECTIONS FOR USE) WILL BE UPDATED WITH ADDITIONAL WARNINGS.

    Description of Event or Problem · 0

    FHC'S PRODUCT 66-IT-1028 WAS USED IN DBS PROCEDURE. DURING THE PROCEDURE, THE SURGICAL TEAM NOTICED A SEPARATED PIECE OF THE MATERIAL IN THE BRAIN. THE ELECTRODE WAS JUST ABOVE, PUSHING THE PIECE. AT THE SAME TIME, THE PATIENT STARTED DYSPNEA AND POTENTIALLY A PEDUNCLE SYNDROME. THE PROCEDURE WAS STOPPED TO STABILIZE THE PATIENT AND WAS SENT TO CT SCAN. CT SCAN CONFIRMED THE PRESENCE OF A PIECE OF 66-IT-1028. THE MATERIAL WAS REMOVED FROM BRAIN WITH NO COMPLICATIONS DURING THE REMOVAL. THE DBS PROCEDURE COULD NOT BE COMPLETED. THE PATIENT IS BEING MONITORED IN INTENSIVE CARE. THE FOLLOWING DAY PATIENT EXHIBITED DIFFICULTY ON OPENING THE EYE AND NO OTHER NEUROLOGICAL DEFICIT. FHC IS STILL WAITING FOR MORE NEWS ABOUT RECOVERY OF THE PATIENT AND ALSO FOR THE RETURN OF 66-IT-1028 FROM FACILITY TO INVESTIGATE FURTHER ON THIS DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED YET.

    Description of Event or Problem · 1

    FHC'S PRODUCT 66-IT-1028 WAS USED IN DBS PROCEDURE. DURING THE PROCEDURE, THE SURGICAL TEAM NOTICED A SEPARATED PIECE OF THE MATERIAL IN THE BRAIN. THE ELECTRODE WAS JUST ABOVE, PUSHING THE PIECE. AT THE SAME TIME, THE PATIENT STARTED DYSPNEA AND POTENTIALLY A PEDUNCLE SYNDROME. THE PROCEDURE WAS STOPPED TO STABILIZE THE PATIENT AND WAS SENT TO CT SCAN. CT SCAN CONFIRMED THE PRESENCE OF A PIECE OF 66-IT-1028. THE MATERIAL WAS REMOVED FROM BRAIN WITH NO COMPLICATIONS DURING THE REMOVAL. THE DBS PROCEDURE COULD NOT BE COMPLETED. THE PATIENT IS BEING MONITORED IN INTENSIVE CARE. THE FOLLOWING DAY PATIENT EXHIBITED DIFFICULTY ON OPENING THE EYE AND NO OTHER NEUROLOGICAL DEFICIT. FHC IS STILL WAITING FOR MORE NEWS ABOUT RECOVERY OF THE PATIENT AND ALSO FOR THE RETURN OF 66-IT-1028 FROM FACILITY TO INVESTIGATE FURTHER ON THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204195 MICROTARGETING INSERTION TUBE INTRACRANIAL CANNULA HAW FHC, INC 66-IT-1028 223942

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| H
    1 NA Unknown Hospitalization| H