BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2708729 · Received April 11, 2012

    Report

    Report Number
    1721279-2012-00035
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED, CARDIAC LEAD EXTRACTION CONDUCTED IN THE OPERATING ROOM TO REMOVE A RECALLED LEAD (MDT 6949 - RV). THE PATIENT WAS INTUBATED, PREPPED WITH AN ARTERIAL LINE, CVS WAS ON STANDBY, FLUOROSCOPY IN USE, AND BLOOD PRODUCTS AVAILABLE. THE RV LEAD WAS CUT AND PREPPED WITH A LLD-EZ. THE MD BEGAN LASING WITH A 14F SLS II, SCARRING WAS NOTED IN THE POCKET, THE SLS LASED SLOW BUT STEADY. LEAD ON LEAD BINDING WAS NOTED IN RELATION TO THE RA LEAD (MDT 5076) THAT WAS NOT BEING EXTRACTED. LASING PROGRESSED BEYOND THE PROXIMAL COIL, TO THE SVC WHERE IT WAS EVIDENT THE BINDING OF THE LEADS BECAME INCREASINGLY MORE SIGNIFICANT. THE MD MAINTAINED A SLOW, CONSTANT TECHNIQUE THROUGHOUT THE PROCEDURE. THE PATIENT'S ABP MOMENTARILY INCREASED FROM 110 TO 125 AND THEN GRADUALLY DECLINED TO 100, THEN 90. LASING AND TRACTION WERE STOPPED TO MONITOR FLUOROSCOPY AND OBSERVE THE PATIENT'S VITAL SIGNS. AT THIS TIME THE CVS WAS CALLED, HIS PA-C RESPONDED IMMEDIATELY AND SET UP THE PERICARDIOCENTESIS AND CHEST TRAY. THE PATIENT'S ABP CONTINUED TO FALL TO 70, THEN TO 60. WHILE THE SLS WAS BEING REMOVED THE RV LEAD (MDT 6949) CAME OUT WITH IT. A PERICARDIAL EFFUSION WAS NOTED ON FLUOROSCOPY AS THE PATIENT'S HEART BOARDERS BEGAN TO CEASE MOVEMENT. CPR WAS INITIATED, CVS ENTERED THE ROOM AND PERFORMED A SUBXIPHOID WINDOW WITH A DRAIN REMOVING APPROXIMATELY 30 MLS. THE PATIENT'S ABP RESPONDED POSITIVELY TO THIS. THE PATIENT WAS AGAIN OBSERVED AND IT WAS DECIDED TO NOT PROCEED WITH A STERNOTOMY AS THE PATIENT'S VITALS REMAINED STABLE. THE PATIENT WAS EVENTUALLY TRANSFERRED TO THE ICU FOR RECOVERY AND OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R LLED-EZ| CVX-300 EXCIMER LASER| MDT 5076 (RA LEAD)| MDT 6949