BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 4200714 · Received October 24, 2014

    Report

    Report Number
    2954740-2014-50014
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    May 16, 2011
    Report Date
    October 24, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROCATHETER MODEL WAS REPORTED AS UNKNOWN WAS NOT RETURNED. LOCATED PROXIMALLY 11.0 CM OFF THE DISTAL TIP OF THE GREEN INTRODUCER, THE COIL WAS RECEIVED PROTRUDING OUTSIDE THE SHEATH. THE COIL PROTRUDES AT THE DISTAL TIP OF THE SKIVE. THE COIL HAS BEEN STRETCHED AND BUCKLED BACK AT THE PROXIMAL SECTION. THE COIL'S SOCKET RING HAS BEEN BENT PROXIMALLY BACK TOWARD THE COIL'S SOLDERED SECTION. IT WAS FOUND THAT THE COIL'S SOCKET RING WAS SEVERED AT THE SOLDER POINT. A SECTION OF COIL UNRAVELED OUT OF THE SOLDERED SECTION. THE PROXIMAL END OF THE COIL WAS STRETCHED. ADJACENT, BUT DISTAL TO THE STRETCHED COIL IS A SECTION OF COMPRESSION AND BUCKLING. THE DISTAL TO THE DAMAGED SECTION, THE REMAINDER OF THE COIL IS UNDAMAGED. THE COIL WAS RETURNED SEVERELY DAMAGED. THE EVIDENCE STRONGLY SUGGESTS THAT INTERFERENCE INSIDE THE MICROCATHETER CONTRIBUTED TO THE RESISTANCE ENCOUNTERED DURING COIL ADVANCEMENT. THE SOURCE OF THIS INTERFERENCE CANNOT BE DETERMINED. IT ALSO CANNOT BE DETERMINED IF THIS INTERFERENCE WAS OF A FIXED OR DETACHED NATURE. IN ADDITION, WITHOUT THE RETURN OF THE MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT 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

    THE DELTAPLUSH COIL (CPL10015330/G13841) WAS NOT GOING THROUGH THE MICROCATHETER (DETAILS UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679919 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC CPL10015330 G13841

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER (DETAILS UNKNOWN)