BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 4200305 · Received October 24, 2014

    Report

    Report Number
    2954740-2014-50012
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    July 7, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: PROWLER 14 MICROCATHETER (DETAILS UNKNOWN). ROTATING HEMOSTATIC VALVE (DETAILS UNKNOWN). SAME LIKE PRODUCT TO COMPLETE THE PROCEDURE. THE PROWLER 14 MICROCATHETER AND THE HEMOSTATIC VALVE WERE NOT RETURNED. THE DISTAL SECTION OF THE COIL IS UNDAMAGED. NOTE: EVEN AFTER CLEANING BY THE HOSPITAL, A BLOOD CLOT WAS FOUND ADHERING TO THE BALL TIP. COMPRESSION AND BUCKLING WERE FOUND AT THE PROXIMAL SECTION OF THE COIL. THE COIL'S SOCKET RING IS LOCATED OFF TO THE SIDE AND DOWN UNDER THE PET OUTER SHEATH. THIS LOCATION OF THE SOCKET RING DID NOT AFFECT ADVANCEMENT INSIDE THE SHEATH OR MICROCATHETER. THE DAMAGE TO THE COIL WAS DEEMED MINOR AND QUALIFIED FOR MICROCATHETER TESTING. THE DISTORTION FOUND TO THE BALL TIP MOST LIKELY OCCURRED AFTER THE PROCEDURE. THIS DAMAGE EXHIBITS WHAT OCCURS AFTER THE CERECYTE IS EXPOSED TO LIQUID AND THEN IS RESHEATHED. THE BALL TIP IS THEN PUTTING PRESSURE AGAINST THE SIDE WALL OF THE GREEN INTRODUCER WHICH FORMS A DISTORTED BALL TIP. AT NO TIME DURING COIL ADVANCEMENT DID THIS CONDITION AFFECT COIL ADVANCEMENT. USING AN IN-HOUSE PROWLER 14 MICROCATHETER, THE RETURNED COIL WAS INTRODUCED MULTIPLE TIMES WITH NO RESISTANCE FELT. THE COIL WAS THEN ADVANCED THROUGH AND OUT THE DISTAL TIP OF THE MICROCATHETER MULTIPLE TIMES WITH NO PROBLEMS ENCOUNTERED. THE EVIDENCE SUGGESTS THAT INTERFERENCE INSIDE THE MICROCATHETER MAY HAVE CONTRIBUTED TO THE INABILITY TO DEPLOY THE COIL. IT CANNOT BE DETERMINED IF THE INTERFERENCE WAS OF A DETACHED OR FIXED NATURE. THEREFORE, THE EXACT SOURCE AND LOCATION OF THIS INTERFERENCE CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE PROWLER 14 MICROCATHETER AND THE HEMOSTATIC VALVE USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. ADDITIONALLY, REVIEW OF THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS THE RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS - 21 CFR PART 803, MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN WANTED TO DEPLOY THE DELTAPAQ CERECYTE COIL ((B)(4)) DURING THE PROCEDURE, HE FOUND IT COULD NOT BE DEPLOYED. THEN THE PHYSICIAN WITHDREW IT AND CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679577 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC CDF10015230 G13025

    Patients

    Seq Age Sex Outcome Treatment
    1