BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI

    MDR report key: 1692818 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00692
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K031049 AND K050700. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EITHER IMPLAINTED (B) (6) 2009 OR (B) (6) 2010. (B) (4). PMA# OR 510K#: K031049 AND K050700.

    Description of Event or Problem · 1

    AS THE PHYSICIAN WAS POSITIONING THE EIGHTH COIL INTO THE ANEURYSM, DURING THE PROCEDURE TO TREAT THE RECANALIZED ANEURYSM, A LOOP OF ONE OF THE PREVIOUSLY DEPLOYED COILS PROLAPSED INTO THE PARENT VESSEL. THE EIGHTH COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY, TO USE A BALLOON CATHETER TO PUSH THE COIL LOOP BACK INTO THE ANEURYSM. A STENT WAS USED TO SECURE THE COIL LOOP TO THE VESSEL WALL. THE PHYSICIAN WAS NOT ABLE TO IDENTIFY THE COIL THAT HAD PROLAPSED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    AS THE PHYSICIAN WAS POSITIONING THE EIGHTH COIL INTO THE ANEURYSM, DURING THE PROCEDURE TO TREAT THE RECANALIZED ANEURYSM, A LOOP OF ONE OF THE PREVIOUSLY DEPLOYED COILS PROLAPSED INTO THE PARENT VESSEL. THE EIGHTH COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY, TO USE A BALLOON CATHETER TO PUSH THE COIL LOOP BACK INTO THE ANEURYSM. A STENT WAS USED TO SECURE THE COIL LOOP TO THE VESSEL WALL. THE PHYSICIAN WAS NOT ABLE TO IDENTIFY THE COIL THAT HAD PROLAPSED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK159

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention THREE MATRIX2 COILS (BOSTON SCIENTIFIC)| SIX GDC COILS (BOSTON SCIENTIFIC)