BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 4243625 · Received November 11, 2014

    Report

    Report Number
    1721279-2014-00197
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED LEAD EXTRACTION PROCEDURE TO REMOVE ONE 132 MONTH OLD MALFUNCTIONING MDT 6947 RV ICD LEAD. THE PLAN WAS TO EXTRACT THE MALFUNCTIONING 6947 AND PLACE A NEW SINGLE COIL ICD LEAD AND AN INTRACARDIAC LV LEAD. THE 6947 RV LEAD WAS PREPPED WITH AN LLD AND A 16F GLIDELIGHT WAS USED FOR THE EXTRACTION. AFTER ADVANCING THE LASER SHEATH PAST THE ICD LEAD'S PROXIMAL COIL AND APPROACHING THE IVC, IT WAS NOTED THAT THE "HEEL" OF THE LEAD WAS STILL APPROXIMATE TO THE IVC BY FLUOROSCOPY. THE LASER SHEATH WAS ADVANCED TO THIS SEGMENT AND THEN A CONSISTENT DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. AFTER FLUOROSCOPIC EVALUATION AND TEE CONFIRMATION OF AN EFFUSION, THE SURGEON WAS NOTIFIED AND RESCUE PROTOCOL WAS INITIATED. A STERNOTOMY WAS PERFORMED AND AN INJURY IN THE IVC (JUNCTION OF LOWER RA AND IVC JUNCTION) WAS FOUND AND REPAIRED. THE ICD LEAD WAS CUT AND CAPPED WITH THE LLD STILL INSIDE OF THE LEAD AND AN EPICARDIAL LEAD WAS PLACED BY THE SURGEON. THE PATIENT WILL BE FURTHER ASSESSED FOR A NEW RV ICD LEAD AT A LATER DATE. THIS REPORT CAPTURES THE LLD REQUIRING SITUATIONAL ABANDONMENT WITHIN THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727037 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other SPECTRANETICS 16F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| MEDTRONIC 6947 SPRINT QUATTRO RV ICD (IMPL 132 MO)