BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC 10-ULTRASOFT STRETCH RESISTANT COIL

    MDR report key: 862671 · Received June 6, 2007

    Report

    Report Number
    6000078-2007-00155
    Event Type
    Injury
    Date Received
    June 6, 2007
    Date of Event
    May 7, 2007
    Report Date
    May 7, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (COIL [DEVICE IN QUESTION] SEPARATED FROM THE PUSHER WIRE). PMA/510(K)# K001083.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO THE MFR ON 05/07/2007:"PHYSICIAN INITIATED DETACHMENT OF A DETACHABLE COIL [DEVICE IN QUESTION]. THE SETTINGS ON THE POWER SUPPLY WERE RUNNING NORMAL AT 1MA. THERE WAS NO DETACHMENT CONFIRMED. PHYSICIAN WAITED FOR 4-5 MINUTES. HE THEN DECIDED TO VERIFY UNDER FLUOROSCOPY WHETHER THE COIL WAS DETACHED OR NOT. WHEN HE STARTED PULLING BACK THE PUSHER WIRE, THE PHYSICIAN NOTICED THAT THE COIL [DEVICE IN QUESTION] WAS STILL ATTACHED TO IT. HE TRIED TO REPOSITION THE COIL [DEVICE IN QUESTION], BUT THE MICROCATHETER TIP MOVED OUTSIDE THE ANEURYSM. THUS, PHYSICIAN HAD TO PULL BACK THE COIL [DEVICE IN QUESTION]. PULLING BACK, THE COIL [DEVICE IN QUESTION] SEPARATED FROM THE PUSHER WIRE AND REMAINED IN THE ARTERY. TWO (2CM) OF THE PROXIMAL COIL [DEVICE IN QUESTION] WAS HANGING WITHIN THE ICA, THE REST WAS WITHIN THE ANEURYSM. THE PHYSICIAN WAS SUCCESSFUL IN RETRIEVING THE ENTIRE COIL [DEVICE IN QUESTION] WITH A SNARE AND REMOVING IT FROM THE PT." STATUS OF PT CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-ULTRASOFT STRETCH RESISTANT COIL HCG: DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP 343203 9527623

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention