BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD-LOCKING DEVICE

    MDR report key: 2838765 · Received November 19, 2012

    Report

    Report Number
    1721279-2012-00172
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    SPECTRANETICS CORPORATION.
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT REUTNED, STILL INSIDE PATIENT.

    Description of Event or Problem · 1

    THIS WAS A LEAD MANAGEMENT CASE THAT RESULTED IN AN SVC TEAR. AN LLD WAS LEFT INSIDE THE PATIENT. THE IFU ((B)(4)) STATES: WARNING: DO NOT ABANDON A LEAD IN A PATIENT WITH A LLD STILL IN PLACE. SEVERE VESSEL OR ENDOCARDIAL WALL DAMAGE MAY RESULT FROM THE STIFFENED LEAD OR FROM FRACTURE OR MIGRATION OF THE ABANDONED LLD BODY." THE EP WAS EXTRACTING AN MDT 6947 (QUATTRO) THAT HAD BEEN FRACTURED, USING AN LLD-EZ ((B)(4)62). THE EP WAS LASING WITH A GLIDELIGHT 16FR. SIX SECONDS INTO THE SECOND LASER TRAIN, THE EP MET SOME RESISTANCE AND THE ABP DROPPED. AT THAT POINT, THE EP SUSPECTED TAMPONADE, CALLED THE ECHO TEAM, AND ASKED FOR A PERICARD TRAY. THEY WITHDREW ABOUT 400 ML OF BLOOD. THE EP RECOGNIZED THAT MORE THAN A TAMPONADE HAD OCCURRED AND CALLED THE CV SURGEON. THE ECHOCARDIOGRAM DID NOT SHOW THE TEAR. THE PATIENT WAS TRANSFERRED TO THE HYBRID OR. THE CHEST WAS OPENED 30 MINUTES AFTER THE ABP DROP, AND THE PATIENT WAS PUT ON BYPASS. THE SVC TEAR WAS ABOUT 1-1/2 INCHES LONG. THE PATIENT BLED OUT (COLD ARREST) AND HAS MASSIVE BRAIN DAMAGE, IS IN A COMA, AND IS RECOVERING PHYSICALLY BUT BRAIN ACTIVITY IS MINIMAL. THE CAPPED LEAD IS STILL IN THE BODY WITH THE LLD. THIS MDR REPORT IS ASSOCIATED WITH MDR 1721279-2012-00164.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LEAD-LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION. 518-062 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O GLIDELIGHT (B)(4)| CVX 300 EXCIMER LASER| QUATTRO MDT 6947