BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE

    MDR report key: 6639988 · Received June 14, 2017

    Report

    Report Number
    1721279-2017-00112
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    May 22, 2017
    Report Date
    May 22, 2017
    Manufacturer
    SPECTRANETICS
    Product Code
    DRB
    PMA / PMN Number
    K142116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH UNAVAILABLE FROM FACILITY. PATIENT WEIGHT UNAVAILABLE FROM FACILITY. DEVICE LOT NUMBER/EXPIRATION DATE UNAVAILABLE FROM FACILITY.

    Additional Manufacturer Narrative · 1

    DEVICE 510K NUMBER HAS BEEN CORRECTED TO REFLECT THE MOST CURRENT AND UP TO DATE NUMBER, AS OF THE DATE OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT HAVING LEAD EXTRACTION PROCEDURE. THE PHYSICIAN PREPPED THE LEAD WITH AN LLD EZ DEVICE, DEBRIDED THE GENERATOR POCKET AND GAVE THE LEAD MINIMAL TRACTION. THEY QUICKLY NOTICED A BLOOD PRESSURE DROP. RESCUE EFFORTS COMMENCED; PATIENT STABILIZED FOR A PERIOD OF TIME. THE DECISION WAS MADE TO REMOVE THE LEAD. THE PHYSICIAN USED A 14FR GLIDELIGHT LASER SHEATH IN ADDITION TO THE LLD IN PLACE WITHIN THE LEAD, AND WAS ABLE TO ADVANCE THE GLIDELIGHT TO THE LEAD TIP WITHOUT EVER ACTIVATING THE LASER. THE LEAD CAME FREE AND WAS REMOVED. HOWEVER, THE PATIENT'S BLOOD PRESSURE AGAIN DROPPED; IT WAS DETERMINED THAT THE INJURY WAS TO THE RA/IVC JUNCTION. RESCUE EFFORTS COMMENCED; A STERNOTOMY WAS PERFORMED, TEAR WAS REPAIRED, AND PATIENT SURVIVED THE PROCEDURE AND INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422887 SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE LLD DRB SPECTRANETICS 518-062 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER