BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - PLATINUM MICROCOIL

    MDR report key: 4055484 · Received September 3, 2014

    Report

    Report Number
    1226348-2014-00215
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). COMPLAINT CONCLUSION: THE DEVICE WAS RETURNED FOR ANALYSIS. THE TWO POSTS INSIDE THE CAVITY OF THE CONNECTOR WERE RETURNED HAVING BEEN PUSHED BACK INTO THE STRAIN RELIEF. BOTH POSTS INNER DIAMETERS WERE IN AND OUT OF ROUND CONDITION AND WERE BURRED. THEY WERE ALSO MISSING THE CHAMFER AROUND THE INNER DIAMETER. THE LEFT AND RIGHT POSTS APPEAR TO BE BENT. THE CENTER LINE DOES NOT PASS THROUGH THE CENTER OF BOTH POSTS INNER DIAMETERS. NO ADHESIVE OR ANY OTHER INTERFERENCE WAS FOUND ON THE WALL OF THE ELECTRICAL CONNECTOR'S CAVITY. WITH THE CONNECTOR RETURNED WITH THE POSTS ALREADY PUSHED DOWN INSIDE THE STRAIN RELIEF, MULTIPLE CONNECTING CABLES FROM DIFFERENT LOT WERE USED TO TEST THE CONNECTION. ALL THE CONNECTING CABLE PLUGS FIT LOOSELY INSIDE THE ELECTRICAL CONNECTOR'S CAVITY. A TOTAL OF TWELVE SAMPLES MANUFACTURED DURING JULY, AUGUST, AND SEPTEMBER (2010) WERE INSPECTED AND ALL WERE CHAMFERED. THE ELECTRICAL CONNECTOR IS 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. NOTE THE OUT OF ROUND CONDITION BETWEEN THE STRAIN RELIEF'S INSIDE DIAMETER AND THE ELECTRICAL CONNECTOR'S OUTSIDE DIAMETER. ENGINEERING HAS DETERMINED THAT THE DPU'S ELECTRICAL CONNECTOR POSTS ARE MISALIGNED. THE COMPLAINT WAS CONFIRMED BASED ON PRODUCT ANALYSIS. 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 OF THE DPU¿S ELECTRICAL CONNECTOR. CAPA (B)(4) HAS BEEN ISSUED TO ADDRESS THIS COMPLAINT. 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. THIS IS ONE OF 2 MDRS SUBMITTED FOR PATIENT IDENTIFIER # (B)(6).

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO "PRE-TESF' TWO DELTAPAQ PLATINUM MICROCOILS, THE DEVICES COULD NOT PLUG INTO THE ECB CABLE. AFTER THE FIRST DEVICE WOULD NOT CONNECT, A NEW ECB CABLE WAS OPENED, HOWEVER THE PROBLEM STILL EXISTED. BOTH COILS WERE PLACED TO THE SIDE FOR RETURN TO MICRUS, AND AN ADDITIONAL 3X10 COIL WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538156 DELTAPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G10969

    Patients

    Seq Age Sex Outcome Treatment
    1