BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER PASSER, DISPOSABLE, 38 CM

    MDR report key: 6431590 · Received March 24, 2017

    Report

    Report Number
    6431590
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    November 17, 2016
    Report Date
    March 8, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GYK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE THE DR. WAS USING THE "SHUNT PASSER" TO PASS THE TUBING THAT HOLDS THE SHUNT CATHETER FROM THE ABDOMEN TO THE SKULL, HE NOTICED THE TIP OF THE SHUNT PASSER HAD BROKEN OFF. HE PRESUMED THAT IT BROKE OFF SOMEWHERE ALONG THE TRACK FROM THE ABDOMEN TO THE SKULL INSIDE THE PATIENT. HE ATTEMPTED MULTIPLE TIMES TO PALPATE, SEARCH THE WOUNDS, AND ALSO HAD A SECOND DR'S HELP TO USE ULTRASOUND TO SEARCH FOR THE MISSING PIECE. IT COULD NOT BE FOUND. THEY PROCEEDED TO FINISH THE CASE AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214134 CATHETER PASSER, DISPOSABLE, 38 CM CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM GYK MEDTRONIC NEUROSURGERY 38 CM E16643

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR