BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE

    MDR report key: 6801127 · Received August 17, 2017

    Report

    Report Number
    1721279-2017-00166
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    July 25, 2017
    Report Date
    July 25, 2017
    Manufacturer
    SPECTRANETICS
    Product Code
    DRB
    PMA / PMN Number
    K142116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAD EXTRACTION PROCEDURE TO REMOVE AN ICD LEAD DUE TO LEAD FRACTURE. PHYSICIAN UTILIZED AN LLD EZ AND ATTEMPTED TO REMOVE THE LEAD WITH USE OF GLIDELIGHT 14FR & GLIDELIGHT 16FR LASER SHEATHS. PHYSICIAN WAS ABLE TO GET PAST OCCLUSION AND PLACE A WIRE FOR NEW LEAD PLACEMENT BUT COULD NOT EXTRACT THE ICD LEAD. AT THAT TIME PHYSICIAN DECIDED TO ABANDON THE LEAD EXTRACTION AND CAP THE ICD LEAD. LEAD WAS CUT AND CAPPED AND LEFT INSIDE THE PATIENT WITH A PORTION OF THE LLD STILL INSIDE THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581936 SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE LLD DRB SPECTRANETICS 518-062 FLP17E03A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS 16F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER