BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT TUNNELER

    MDR report key: 13662841 · Received March 3, 2022

    Report

    Report Number
    9612007-2022-00006
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 1, 2022
    Report Date
    April 21, 2022
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GYK
    UDI-DI
    10381780034414
    PMA / PMN Number
    K932273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHUNT TUNNELER (990010) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT WAS DISCARDED AS PER CUSTOMER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT DURING VENTRICULO PERITONEAL SHUNT SURGERY, THE BLUE HANDLE OF THE SHUNT TUNNELER (990010) WHICH IS TO BE EXPLANTED FROM THE VALVE GUIDE WAS STUCK. THE DEVICE WAS ALREADY INTRODUCED UNDER THE PATIENT'S SKIN FROM HEAD TO ABDOMEN WHEN THE ISSUE HAPPENED. THE SURGEON HAD TO APPLY FORCE TO TAKE IT OUT WHICH TWISTED THE TUNNELER. THEY UNTWISTED THE SYSTEM AFTER, THE TUNNELER WAS TORN, AND THERE WAS RISK OF INJURY FOR PATIENT AND SURGEON. NO INJURY WAS REPORTED. THERE WAS INCREASED SURGERY TIME OF 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787925 SHUNT TUNNELER VALVE ACCESSORIES GYK INTEGRA NEUROSCICENCS IMPLANTS SA 990010 10381780034414

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male