BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL HYDROFRAME 10-SYSTEM COIL

    MDR report key: 1901407 · Received October 29, 2010

    Report

    Report Number
    2032493-2010-00025
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL EVALUATION REVEALED THAT THE DEVICE WAS RETURNED WITH THE IMPLANT DETACHED FROM THE DELIVERY PUSHER. THE IMPLANT WAS NOT RETURNED FOR EVALUATION, AS IT IS WITHIN THE PATIENT. THE MOST PROXIMAL 31.0" OF THE DELIVERY PUSHER WAS RETURNED. THE REMAINDER OF THE PUSHER WAS CUT/REMOVED AND NOT INCLUDED FOR EVALUATION. ROOT CAUSE: THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED AS THE ENTIRE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLACEMENT OF THE 3RD EMBOLIZATION COIL WITHIN A BASILAR TIP ANEURYSM, THE IMPLANT DETACHED FROM THE DELIVERY PUSHER WITHOUT USE OF THE DETACHMENT CONTROLLER PARTIALLY WITHIN THE MICROCATHETER AND PARTIALLY WITHIN THE ANEURYSM. SUCTION WAS APPLIED THROUGH THE MICROCATHETER WITH A SYRINGE TO RETRACT THE IMPLANT. THIS ATTEMPT WAS SUCCESSFUL. THE DISTAL PORTION OF THE COIL BECAME STUCK WITHIN THE PONTINE PERFORATOR WITH THE MAJORITY OF THE IMPLANT IN THE LEFT VERTEBRAL ARTERY. TWO GOOSENECK SNARES WERE USED TO SNARE THE DEVICE WITHOUT SUCCESS. AN ALLIGATOR RETRIEVAL DEVICE WAS USED TO REMOVE THE COIL FROM THE ANEURYSM AND MICROCATHETER. THERE WAS NO CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL HYDROFRAME 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 100833HFRM-V 10062815

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention