BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2944462 · Received February 5, 2013

    Report

    Report Number
    1721279-2013-00007
    Event Type
    Death
    Date Received
    February 5, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 24, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A REPORTED LEAD EXTRACTION CONDUCTED IN THE EP LAB TO REMOVE A 12 YEAR OLD, MALFUNCTIONING MDT 6945 - RV. THE PATIENT ALSO HAD A RA (UNKNOWN MODEL#) WHICH WAS TO BE LEFT IN PLACE. THE PATIENT WAS PREPPED WITH ARTERIAL LINES, CVS ON STANDBY AND FLUOROSCOPY USED THROUGHOUT THE PROCEDURE. THE MDT 6945 WAS CUT AND PREPPED WITH A LLD-EZ AND LASING BEGAN WITH 14F SLS II. THE PROGRESSION OF THE LASER CEASED JUST PRIOR TO THE SVC/RA JUNCTION AND THE MD UPSIZED TO A 16F SLS II AND WAS ABLE TO PROGRESS PAST THE POINT OF BINDING. JUST SECONDS AFTER THIS THE PATIENT'S ABP RAPIDLY DROPPED. THE CVS ARRIVED WITHIN 5 MINUTES OF BEING CALLED AND CHOSE NOT TO OPEN THE PATIENT'S CHEST BUT RATHER INSERT A BALLOON INTO THE SITE OF INJURY IN HOPES OF STOPPING THE BLEEDING AND CPR WAS STARTED. UNFORTUNATELY THE PATIENT DID NOT SURVIVE THIS RESCUE ATTEMPT AND DIED ON THE TABLE. THE INJURY SITE AND SIZE WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47885 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORPORATION 500-013 CKK12C22A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death LLD-EZ| MDT 6945 SPRINT| RA UNKNOWN MODEL#| 14F SLS II| CVX-300 EXCIMER LASER SYSTEM