BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 3801011 · Received May 8, 2014

    Report

    Report Number
    1721279-2014-00070
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAD MANAGEMENT CASE TO EXTRACT ONE LV LEAD (4195) DUE TO LEAD DYSFUNCTION WITH STENOSIS IN THE CORONARY SINUS OSTIUM. AN LLD EZ WAS INSERTED INTO THE LEAD AND THE PROCEDURE WAS STARTED LASING WITH A 12F SLS II FOR APPROXIMATELY 10 SECONDS IN THE SUBCLAVIAN VESSEL BEFORE BEING ABLE TO PASS THE LASER INTO THE PROXIMAL SVC. LASING WAS RESUMED AGAIN IN THE MID SVC FOR 5 SECONDS. THE PHYSICIAN THEN PUSHED THE SLS II MECHANICALLY TO THE TIP OF THE LEAD THEN USED IT AS COUNTER TRACTION FOR LEAD RELEASE. AT THAT TIME, THE BLOOD PRESSURE WENT DOWN AND A PERICARDIAL EFFUSION WAS NOTED ON TTE. A PERICARDIOCENTESIS WAS PERFORMED AND THEN A STERNOTOMY. BYPASS WAS STARTED AND THE INJURY IN THE CORONARY SINUS OSTIUM WAS REPAIRED. SEVERAL ATTEMPTS WERE MADE TO STABILIZE THE PATIENT'S HEMODYNAMICS HOWEVER THESE EFFORTS WERE UNSUCCESSFUL AND THE PATIENT DID NOT SURVIVE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277674 SPECTRANETICS LASER SHEATH II 12F SLS II MFA SPECTRANETICS CORPORTATION 500-001 WM12M12F

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| MDT FIDELIS CARDIAC LEAD (IMPL. 72 MO)| MDT 4195 STARFIX CARDIAC LEAD (IMPL. 57MO)| MDT QUATTRO CARDIAC LEAD (IMPL. 72MO)| SPECTRANETICS LEAD LOCKING DEVICE EZ