BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2180880 · Received July 21, 2011

    Report

    Report Number
    1721279-2011-00042
    Event Type
    Death
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS EMERGENTLY TRANSPORTED TO THE OPERATING ROOM WHERE A STERNOTOMY WAS PERFORMED. A TEAR IN THE MID-SVC WAS FOUND AND REPAIRED. THE PATIENT WAS STABILIZED AND TRANSPORTED TO THE ICU BUT UNFORTUNATELY NEVER REGAINED CONSCIOUSNESS AND LIFE SUPPORT WAS TERMINATED APPROXIMATELY ONE WEEK LATER. NO DEVICES WERE RETAINED FOR RETURN ENGINEERING ANALYSIS. A LHR REVIEW WAS CONDUCTED AND FOUND NO NON-CONFORMANCES OR ISSUES.

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED, CARDIAC LEAD (RA AND RV - (B)(6)) REMOVAL PROCEDURE CONDUCTED IN THE EP LAB DUE TO AN ACUTE INFECTION. ARTERIAL LINE WAS PLACED WITH ACTIVE FLUOROSCOPY AND TEE AVAILABLE THROUGHOUT THE PROCEDURE. THE MD PREPPED THE LEADS WITH BOTH A LLD #2 AND A LLD-EZ AND BEGAN LASING WITH THE 14F SLS II. WHILE MOVING BACK AND FORTH BETWEEN THE TWO LEADS (WITH THE ADDITION OF THE TEFLON OUTER SHEATH) THE RA LEAD (4469) BEGAN TO SEPARATE. THE LASER SHEATH WAS THEN UPSIZED TO THE 16F SLS II, AGAIN WITH THE ADDED TEFLON SHEATH. MD THEN BEGAN LASING THE RV LEAD (0184), ADVANCED TO THE AREA OF THE TRICUSPID VALVE WITH THE OUTER SHEATH AT THE RA JUNCTION AREA. THE RV LEAD STARTED TO PULL BACK, AND THE MD THEN PULLED THE SHEATH BACK AS WELL. IT WAS NOTED THE HEART BORDER WASN'T MOVING ON FLUOROSCOPY AS WELL AS A SLIGHT DECLINE IN THE ARTERIAL BLOOD PRESSURE. AT THIS POINT A STAT TEE WAS CALLED FOR AND CT SURGEON BACKUP. TEE CONFIRMED A SMALL PLEURAL EFFUSION WHICH WAS DECIDED TO BE "NORMAL" IN SIZE AND AN ATTEMPT AT CONTINUING THE EXTRACTION WAS MADE. ONCE THE MD MOVED THE LASER FROM ITS EXISTING POSITION, THE ARTERIAL BLOOD PRESSURE DROPPED SIGNIFICANTLY. THE DECISION WAS MADE AT THAT TIME TO INTERVENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORP. 500-013 CKK10L23C6

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death BSC 0184: (RV)| CPI-GUIDANT 4469: (RA)| LLD-EZ: ((B)(4))| 14F SLS II: ((B)(4))| CVX-300 EXCIMER LASER: (SERIAL# (B)(4))| LLD# 2: ((B)(4))