BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1897688 · Received November 3, 2010

    Report

    Report Number
    1721279-2010-00065
    Event Type
    Death
    Date Received
    November 3, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USED IN THE CASE HAS NOT BEEN RETURNED FOR AN ENGINEERING ANALYSIS. AN INTERNAL LOT HISTORY REVIEW WAS COMPLETED AND FOUND NO ISSUES.

    Description of Event or Problem · 1

    THIS WAS A CARDIAC LEAD REMOVAL PROCEDURE CONDUCTED IN THE CARDIAC CATHETER LAB WITH THE INTENT OF REMOVING A FRACTURED ICD LEAD (RV IMPLANTED IN 2005). THE MD ATTEMPTED TO ATTACH A LLD#2 TO THE DISTAL TIP OF THE RV LEAD, BUT WAS UNABLE TO REACH THE DISTAL COIL. HE THEN OPENED A LLD-EZ AND WAS SUCCESSFUL REACHING THE DISTAL ELECTRODE OF THE LEAD. THIS CONFIRMED A LEAD FRACTURE WAS PRESENT. THE MD THEN TIED SUTURE TO INSULATION AFTER LOCKING THE LLD-EZ INSIDE THE INNER LUMEN. THE MD USED A 14F SLS WITH A 33CM MEDIUM VISISHEATH TO LASE PAST THE PROXIMAL SHOCKING COIL WITHOUT DIFFICULTY. WHEN THE MD REACHED THE PROXIMAL END OF THE DISTAL SHOCKING COIL, A SUDDEN DROP IN THE PATIENT'S ARTERIAL BLOOD PRESSURE WAS NOTED. FLUOROSCOPY REVEALED A SLOWING OF THE CARDIAC SILHOUETTE AND THE CT SURGEON/HEART TEAM WERE CALLED IMMEDIATELY. EMERGENT RESUSCITATION EFFORTS WERE EXECUTED BY DR (B)(6) TO INCLUDE A PERCUTANEOUS NEEDLE PLACED SUB-XIPHOID TO REMOVE EXCESS BLOOD AND FLUID IN PERICARDIUM. BLOOD PRESSURE CAME BACK, BUT THEN DROPPED BACK DOWN. PT WAS THEN MOVED TO THE OPERATING ROOM, HEART ROOM FOR FURTHER REPAIR. A STERNOTOMY WAS PERFORMED BY THE CT SURGEON AND MULTIPLE UNITS OF BLOOD AND FLUIDS GIVEN. THE PATIENT WAS UNABLE TO RECOVER FROM THE EXCESSIVE BLOOD LOSS AND EXPIRED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 14F SLS II MFA SPECTRANETICS CORP. 500-012 C10B25B

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death CVX-300 EXCIMER LASER:(B)(4)| VISISHEATH: (501-112/(B)(4))| LLD#2: (518-019/FLD10F07C)| LLD-EZ: (518-062/FLD10D13A)