BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 6600574 · Received May 31, 2017

    Report

    Report Number
    3008264254-2017-00050
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    April 5, 2017
    Report Date
    April 12, 2017
    Manufacturer
    CODMAN SHURTLEFF INC.
    Product Code
    HCG
    UDI-DI
    10886704030409
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Additional Manufacturer Narrative · 1

    PRO CODE: KRD/HCG. THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, WHEN THE SURGEON ADVANCED AN ORBIT GALAXY COIL (640CF0925/ 17366792) INTO THE UNSPECIFIED MICROCATHETER, THE COIL DETACHED FROM THE DETACH ZONE. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER, AND THE MICROCATHETER DID NOT APPEAR DAMAGED. THE SURGEON USED ANOTHER COIL TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO POTENTIAL ADVERSE EVENTS. NO ADDITIONAL INFORMATION COULD BE OBTAINED. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384754 ORBIT GALAXY DETACHABLE COIL SYSTEM NEUROVASCULAR EMBOLIZATION DEVICE HCG CODMAN SHURTLEFF INC. NA 17366792 10886704030409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown