BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPLEX HYPERSOFT 3D

    MDR report key: 8525510 · Received April 17, 2019

    Report

    Report Number
    2032493-2019-00087
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 27, 2018
    Report Date
    March 18, 2018
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    UDI-DI
    00816777021069
    PMA / PMN Number
    K131948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AN EMAIL WAS RECEIVED ON 4/24/19 FROM EMMA LEE, AND EMPLOYEE OF THE DISTRIBUTOR (B)(4), INC, WITH MORE INFORMATION REGARDING THE INCIDENT. THE COIL DETACHED WITHIN THE MICROCATHETER DURING ADVANCEMENT, AND THE COIL WAS REMOVED WITH THE MICROCATHETER. ANALYSIS: THE PUSHER WAS RECEIVED FOR ANALYSIS. THE IMPLANT, INTRODUCER, AND MICROCATHETER WERE NOT RECEIVED. THE GOLD CONNECTORS AND HYPOTUBE OF THE PUSHER WERE OBSERVED TO BE UNDAMAGED. A STRETCHED COIL WAS FOUND AT THE HYPOTUBE BODY COIL TRANSITION. THE REST OF THE BODY COILS WERE UNDAMAGED. THE STRAIN RELIEF WAS OBSERVED TO BE IN GOOD CONDITION AND UNBURNT. THE MONOFILAMENT WAS OBSERVED WITHIN THE ATTACHMENT BOND GLUE. WHEN THE STRAIN RELIEF WAS REMOVED, THE SOLDER JOINTS WERE STILL INTACT. THE DISTAL COIL WAS STRETCHED IN ORDER TO REMOVE THE MONOFILAMENT, HOWEVER IT WAS FOUND THAT THE MONOFILAMENT HAD BROKEN AT THE ATTACHMENT BOND GLUE. THE TAIL OF THE MONOFILAMENT COULD NOT BE IDENTIFIED, AS IT WAS WITHIN THE GLUE. BASED UPON THE INVESTIGATION ANALYSIS AND AVAILABLE INFORMATION, THE REPORTED COMPLAINT IS CONFIRMED. THE MONOFILAMENT WAS BROKEN AT THE ATTACHMENT BOND GLUE, WHICH RESULTED IN THE PRE-DETACHMENT. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED AS THE MONOFILAMENT PROFILE COULD NOT BE IDENTIFIED IN THE ATTACHMENT BOND, AND THE IMPLANT WAS NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE APPROVED DEVICE HISTORY RECORDS INDICATED THE LOT MET ALL RELEASE CRITERIA. A LOT HISTORY TRENDING REVIEW WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE OR DIFFICULT COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL "PRE-DETACHED." THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT'S CONDITION WAS REPORTED TO BE "NORMAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316492 MICROPLEX HYPERSOFT 3D EMBOLIZATION COIL HCG MICROVENTION, INC. 100256HS3D-V 1705261W5 00816777021069

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR