BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENEGADE

    MDR report key: 832325 · Received March 28, 2007

    Report

    Report Number
    6000125-2007-00013
    Event Type
    Death
    Date Received
    March 28, 2007
    Date of Event
    February 22, 2007
    Report Date
    February 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK
    Product Code
    DQO
    PMA / PMN Number
    K023681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS THEN PULLED FURTHER INTO THE MICROCATHETER WITH THE INTENT OF TOTALLY REMOVING IT. THIS BEGAN TO DESTABILIZE THE OTHER COILS THAT HAD BEEN POSITIONED IN THE GDA. THE COIL WAS THEN READVANCED INTO THE GDA AND WITH ADVANCING THE MICROCATHETER AND ANGIOGRAPHIC CATHETER OVER THE WIRE, WIRE AND COIL EVENTUALLY SEPARATED. THESE MANEUVERS CAUSED A DISSECTION OF THE COMMON HEPATIC ARTERY AND BOTH INTERLOCK COILS WERE DESTABILIZED ENOUGH TO ADVANCE INTO THE RIGHT HEPATIC ARTERY. THE DISSECTION WAS STENTED WITH A GOOD COSMETIC RESULT AND BOTH INTERLOCK COILS WERE REMOVED WITH A SNARE. COMPLETION ARTERIOGRAM SHOWED SIGNIFICANT COMPROMISE FLOW TO THE RIGHT HEPATIC LOBE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS OBTAINED FROM BOTH A USER MED WATCH REPORT AND A BOSTON SCIENTIFIC SALES REP: A PT UNDERWENT AN EMBOLIZATION OF THE GASTRIC DUODENAL ARTERY IN PREPARATION FOR EVENTUALLY YTTRIUM-90 THERAPY OF THE RIGHT HEPATIC ARTERY. SEVERAL MATRIX MICRO COILS HAD BEEN PLACED IN THE MID AND DISTAL GDA. A SINGLE 4 MM X 15 CM INTERLOCK COIL WAS PLACED IN THE PROXIMAL GDA THROUGH A RENEGADE MICROCATHETER UNEVENTFULLY. THERE WAS STILL SIDE BRANCH FILLING FROM THE GDA AND AN ADDITIONAL 4 MM X 8 CM INTERLOCK COIL WAS THEN ADVANCED THROUGH THE MICROCATHETER TO DEPLOY IT IN THE PROXIMAL GDA. THE COIL WAS ADVANCED BEYOND THE DISTAL END OF THE CATHETER WITH THE PUSHER WIRE, AND IT WAS NOTED FLUOROSCOPICALLY THAT THE COIL DID NOT DETACH FROM THE WIRE. THE COIL WAS PULLED BACK IN THE MICROCATHETER AND THE MICROCATHETER ADVANCED OVER THE COIL IN AN ATTEMPT TO DETACH IT WHICH WAS UNSUCCESSFUL. ADDITIONAL INFORMATION PROVIDED BY DR ON 03/19/2007 INDICATED THAT THE PT WAS MOVED TO HOSPICE WHERE HE EXPIRED DUE TO PANCREATITIS. THIS MED WATCH IS BEING FILED FOR THE RENEGADE CATHETER USED DURING THIS EVENT. TWO ADDITIONAL MED WATCH REPORTS (6000125-2007-00011 AND 6000125-2007-00012) WERE FILED FOR THE TWO INTERLOCK COILS USED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE MICROCATHETER DQO BOSTON SCIENTIFIC CORK UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| R