BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 3122718 · Received May 21, 2013

    Report

    Report Number
    1721279-2013-00072
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE HYBRID OR TO REMOVE 2 LEADS (SJM 1580 AND SJM 1488) FOR NON-FUNCTION. THE PHYSICIAN PREPPED THE SJM 1488 LEAD WITH AN LLD#1, BUT WAS ONLY ABLE TO GET THE TIP JUST PAST THE CLAVICLE. THE SJM 1580 WAS PREPPED WITH AN LLD-EZ, BUT WAS ABLE TO GET IT TO THE DISTAL COIL, NOT ALL THE WAY TO THE TIP. USING A 14F GLIDELIGHT, THE PHYSICIAN BEGAN ON THE SJM 1488 LEAD. HE MADE PROGRESS TO THE CLAVICLE, BUT NOTICED THE LEAD UNRAVELING. HE SWITCHED TO THE SJM 1580, AND PROGRESS WAS MADE TO THE CLAVICLE. AT THIS TIME BLEEDING IN THE POCKET WAS NOTICED BY THE CT SURGEON. THERE WAS A TEAR IN THE CEPHALIC VEIN AND THIS WAS REPAIRED BY THE SURGEON. THE PHYSICIAN THEN ADDED AN OUTER VISISHEATH, AND CONTINUED THE EXTRACTION OF THE SJM 1580 LEAD. PROGRESS WAS MADE JUST PAST THE CLAVICLE WHEN BLEEDING WAS AGAIN NOTICED IN THE POCKET BY THE CT SURGEON. AN ADDITIONAL REPAIR WAS MADE TO THE CEPHALIC VEIN. THE DECISION WAS MADE NOT TO CONTINUE WITH THE EXTRACTION. BOTH LLD'S WERE ATTEMPTED TO BE UNLOCKED AND REMOVED, BUT THIS ATTEMPT WAS UNSUCCESSFUL ON BOTH LEADS. THE LLD'S WERE CUT AND THE LEADS CAPPED AND LEFT IN THE POCKET. TWO NEW LEADS WERE INSERTED AND THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224114 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 FLP13C05A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 14F GLIDELIGHT| VISISHEATH| LLD#1| SJM 1580 RIATA LEAD| CVX-300 EXCIMER LASER (SN 1478)| SJM 1488 LEAD