BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSATILE RANGE FILL COIL (VFC)

    MDR report key: 3040169 · Received April 3, 2013

    Report

    Report Number
    2032493-2013-00017
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE HAS NOT BEEN PERFORMED AS IT HAS NOT BEEN RETURNED. A PORTION REMAINS WITHIN THE PATIENT AND THE DELIVERY PUSHER WAS REPORTED TO BE DISCARDED BY THE USER CENTER. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON TREATING AN ACOM ANEURYSM, COILS WERE DEPLOYED. AFTER PLACING THE THIRD COIL, AN ATTEMPT WAS MADE TO DETACH THE COIL. MULTIPLE ATTEMPTS WERE MADE TO DETACH THE COIL UNSUCCESSFULLY. AN ATTEMPT TO PULL THE DEVICE DURING THE DETACHMENT CYCLE WAS MADE UNSUCCESSFULLY. THE COIL WAS RETRACTED AND IN DOING SO, THE COIL STRETCHED. THE COIL WAS STRETCHED AND SECURED AT THE GROIN PUNCTURE SITE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136253 VERSATILE RANGE FILL COIL (VFC) EMBOLIZATION COIL HCG MICROVENTION, INC. VFC030610-V 130128H5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention