BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - PLATINUM MICROCOIL

    MDR report key: 4052717 · Received September 2, 2014

    Report

    Report Number
    1226348-2014-00211
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT CONCLUSION: THE DEVICE WAS RETURNED FOR ANALYSIS. THE ELECTRICAL CONNECTOR COULD BE FULLY PLUGGED INTO THE CONNECTING CABLE WITH SOME FRICTION ENCOUNTERED. NO ADHESIVE OR OTHER INTERFERENCE WAS FOUND ON THE INSIDE THE CAVITY WALLS OF THE DPU'S ELECTRICAL CONNECTOR. THE CHAMFER ON THE INSIDE DIAMETER WAS MISSING ON BOTH THE LEFT AND RIGHT POSTS. THE ELECTRICAL CONNECTOR WAS MISSING THE LEAD-IN CHAMFER ON THE OUTSIDE EDGE OF THE CAVITY. HOWEVER, THIS DID NOT HAVE ANY EFFECT ON INSERTING THE CONNECTING CABLE'S PLUG PAST THIS AREA. IT WAS DETERMINED THAT THE DPU'S ELECTRICAL POSTS WERE MISALIGNED. THE COMPLAINT WAS CONFIRMED, AS FRICTION WAS ENCOUNTERED WHEN THE ELECTRICAL CONNECTOR WAS PLUGGED INTO THE CONNECTING CABLE. THE MOST LIKELY ROOT CAUSE OF THE DEVICE POSITIONING UNIT'S (DPU) FAILURE TO CONNECT INTO THE ENPOWER CONTROL CABLE (ECB) WAS DUE TO THE MISALIGNMENT OF THE DPU'S ELECTRICAL CONNECTOR'S POSTS AND THE MISSING LEAD-IN CHAMFER LOCATED AT THE INSIDE DIAMETER OF BOTH ELECTRICAL POSTS. AN INTERNAL INVESTIGATION WAS CONDUCTED TO ADDRESS THIS ISSUE. 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 ATTEMPTING TO "PRE-TEST" THE DELTAPLUSH PLATINUM MICROCOIL, IT WOULD NOT PLUG INTO THE ECB CABLE. THE TECH COULD NOT MAKE THE CONNECTION BETWEEN THE TWO ENDS OF THE CONNECTORS. THIS COIL WAS PLACED TO THE SIDE FOR RETURN TO MICRUS, AND SEVERAL ADDITIONAL COILS WERE SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533391 DELTAPLUSH - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G11371

    Patients

    Seq Age Sex Outcome Treatment
    1