BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD LOCKING DEVICE

    MDR report key: 2807194 · Received October 27, 2012

    Report

    Report Number
    1721279-2012-00149
    Event Type
    Death
    Date Received
    October 27, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 3, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION TO REMOVE A NON-FUNCTIONAL RV PACING LEAD CPI-GDT 4024 (198 MTHS OLD) CONDUCTED IN THE EP LAB. PATIENT WAS PREPPED PER HRS RECOMMENDED STANDARDS. THE MD PREPPED THE LEAD WITH A LLD (UNKNOWN MODEL#) AND USED A 12F SLS II WITH THE TEFLON OUTER SHEATH. APPROXIMATELY 3 SECONDS OF LASING TO GET INTO THE VESSEL AND APPROXIMATELY 3 SECONDS FURTHER IN THE SUBCLAVIAN, WHERE SOME BINDING RESISTANCE WAS EXPERIENCED. THE MD WAS ABLE TO MANUALLY ADVANCE THE LASER SHEATH AND OUTER SHEATH TO THE END OF THE RV LEAD WITHOUT USING THE LASER. HE THEN PULLED BOTH THE LASER AND OUTER SHEATHS OUT OF THE BODY AND REVERSED THE OUTER SHEATH TO WHERE THE BLUNT END OF THE TEFLON WOULD BE THE DISTAL END, AND THE BEVEL WAS AT THE PROXIMAL. THE LASER SHEATH AND TEFLON OUTER SHEATH WERE ADVANCED TO THE RING ELECTRODE, RV APEX WITHOUT LASING. COUNTER TRACTION WAS THEN PLACED ON THE LEAD WITH THE OUTER SHEATH. THERE WAS SIGNIFICANT TISSUE ON THE TIP OF THE PASSIVE RV LEAD. THE PRESSURE STARTED DROPPING SOON AFTER EXTRACTION OF THE LEAD AND THE SURGICAL TEAM WAS CALLED IN QUICKLY. AN EMERGENT STERNOTOMY WAS PERFORMED WITHIN ~15 MINUTES OF THE INITIAL ABP DECLINE AND SIGNIFICANT BLOOD LOSS HAD OCCURRED BY THIS TIME. EVEN THOUGH THE PERFORATION IN THE RV WAS REPAIRED THE PATIENT WAS UNABLE TO SURVIVE THE SURGERY AND DIED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LOCKING DEVICE LLD MFA SPECTRANETICS CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death CVX-300 EXCIMER LASER SYSTEM| CPI-GDT 4024 BI IS-1 PASSIVE ATRIAL| 12F SLS II