BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN BACTISEAL VENTRICULAR CATHETER

    MDR report key: 5876410 · Received August 15, 2016

    Report

    Report Number
    1226348-2016-10576
    Event Type
    Malfunction
    Date Received
    August 15, 2016
    Date of Event
    July 21, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K003322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WA RETURNED AND EVALUATED. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND NO DISCREPANCIES WERE NOTED. IT WAS CLEAR FROM THE SHAPE OF THE CUT ON THE RETURNED PRODUCT THAT THE LUMBAR CATHETER WAS RETRACTED (EITHER WITH OR WITHOUT THE GUIDEWIRE STILL POPULATED IN THE CATHETER) WHILE THE TUOHY NEEDLE REMAINED IN POSITION. THIS RESULTED IN THE SHARP HEEL EDGE OF THE NEEDLE CUTTING THROUGH THE LUMBAR CATHETER. THE LUMBAR CATHETER KIT IFU (IFU-LCN-205456001) HAS THE FOLLOWING 2 WARNINGS TO HELP PREVENT THIS FROM OCCURRING IN THE FIELD: "WARNINGS. TO AVOID DAMAGE TO THE CATHETER, CARE MUST BE TAKEN NOT TO WITHDRAW THE CATHETER FROM THE NEEDLE IN ORDER TO REPOSITION IT IN THE SUBARACHNOID SPACE. IF THE CATHETER MUST BE REMOVED, WITHDRAW THE NEEDLE AND CATHETER SIMULTANEOUSLY." "WARNING: TO MINIMIZE THE RISK OF DAMAGE TO THE CATHETER, TAKE CARE NOT TO PULL BACK ON OR WITHDRAW THE CATHETER AFTER INSERTION INO THE NEEDLE. IF THE CATHETER MUST BE REMOVED, WITHDRAW THE NEEDLE AND CATHETER SIMULTANEOUSLY." TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    A DETAILED DESCRIPTION OF THE EVENT OR PROBLEM THAT PROMPTED THIS COMPLAINT. USING THE CATHETER KIT, THE DRAIN HAS TORN. THE NAME OF THE INSTITUTION INVOLVED IN THIS INCIDENT. (B)(6). THE PRODUCT CODE AND SERIAL NUMBER OF THE DEVICE INVOLVED. PRODUCT #: 82-1707, LOT: 737960. THE DATE THE EVENT OCCURRED. (B)(6) 2016. THE DATE YOU WERE FIRST NOTIFIED OF THE INCIDENT. ON 22ND OF JULY 2016. DID THE INCIDENT OCCUR INTRA OPERATIVELY? YES. DID THE INCIDENT CAUSE A DELAY IN SURGERY OVER 30 MINUTES? NO. WHAT ACTION WAS TAKEN TO RESOLVE THE ISSUE? USING NEW IMPLANT. WERE THERE ANY ADVERSE CONSEQUENCES TO THE PATIENT? NO. IS THE DEVICE BEING RETURNED FOR EVALUATION? YES, IT WILL BE SHIPPED SOON. PER AFFILIATE: I'VE RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT DESCRIPTION WHICH SAYS THAT "AFTER IMPLANTING THE DRAIN THROUGH THE TUOCHY NEEDLE, THE MANDRENE COULDN'T BE WITHDRAWN. SO THEY REMOVED THE DRAIN TOGETHER WITH THE MANDRENE BUT IT COULDN'T BE WITHDRAWN FROM THE DRAIN AND THE TIP OF THE DRAIN WAS BROKEN. THEN THEY USED A SAME-LIKE PRODUCT WITHOUT ANY PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528316 CODMAN BACTISEAL VENTRICULAR CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. 737960

    Patients

    Seq Age Sex Outcome Treatment
    1