BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1961524 · Received January 12, 2011

    Report

    Report Number
    1721279-2010-00093
    Event Type
    Death
    Date Received
    January 12, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED, CARDIAC REMOVAL CASE CONDUCTED IN THE OPERATING ROOM WITH BOTH ARTERIAL LINE PLACEMENT AND FLUOROSCOPY THROUGHOUT THE PROCEDURE. THE PLAN WAS TO REMOVE ONE, MALFUNCTIONING RV LEAD ORIGINALLY IMPLANTED IN 2002. THE MD PREPPED THE LEAD FOR EXTRACTION, ATTACHED A LLD-EZ TO THE DISTAL TIP OF THE RV LEAD AND BEGAN LASTING WITH A 14F SLS/VISISHEATH 23 CM. AFTER ENCOUNTERING SIGNIFICANT FIBROSIS THE MD REQUESTED THE VISISHEATH 43 CM. THE LASTING CONTINUED UNTIL THE PT'S ARTERIAL BLOOD PRESSURE WAS NOTED TO HAVE FALLEN FROM 108 TO 80 IN A MATTER OF SECONDS. THE CT SURGEON WAS CALLED AND WITHIN 4 MINUTES A STERNOTOMY WAS PERFORMED. A RA/SVC PERFORATION WAS NOTED, BUT DESPITE THE OPERATING ROOM TEAM'S BEST EFFORTS THE PT WAS UNABLE TO SURVIVE THE SURGERY. NO DEVICES WERE RETAINED FOR THE RETURN ENGINEERING ANALYSIS, HOWEVER AN INTERNAL LHR REVIEW SHOWED NO NON-CONFORMANCES OR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 14F SLS II MFA SPECTRANETICS CORP. 500-012 CJJ10D21C

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death CVX-300 EXCIMER LEASER (SERIAL# (B)(4))| LLD-EZ (518-062/(B)(4))| VISISHEATH M 43CM (501-014/(B)(4))| VISISHEATH M 23CM (501-214/(B)(4))