BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 5564980 · Received April 8, 2016

    Report

    Report Number
    1721279-2016-00049
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    March 25, 2016
    Report Date
    March 25, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    DRB
    PMA / PMN Number
    K142116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    PATIENT WAS TO UNDERGO A LEAD EXTRACTION PROCEDURE TO REMOVE ONE RA LEAD AND ONE RV LEAD DUE TO INFECTION. EACH OF THE LEADS WAS PREPPED WITH AN LLD-EZ((B)(4)). THE PROCEDURE WAS STARTED WITH EXTRACTION OF RV LEAD USING 12FR SLSII BUT THE DEVICE WAS NOT ADVANCED AT THE LEAD ON LEAD BIND SITE. THE PHYSICIAN SWITCHED TO THE RA LEAD BUT AGAIN THE DEVICE WAS NOT ADVANCED AT THE ADHESION. THE DEVICE WAS UP-SIZED TO 14FR SLSII. THE RA LEAD WAS EXTRACTED WITH COUNTER TRACTION AND THEN THE RV LEAD WAS EXTRACTED SUCCESSFULLY. ABOUT 5 MINUTES AFTER THE RV LEAD WAS EXTRACTED, THE PATIENTS BLOOD PRESSURE DROPPED FROM 105 TO 40 MMHG. THE CARDIAC SURGEON IMMEDIATELY PERFORMED A SMALL INCISION AND CONFIRMED A PERFORATION AT THE CADIAC APEX. BLEEDING WAS STOPPED AFTER PERFORMING DRAINAGE AND HEMATOMA EVACUATION. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT IS BEING MADE ON THE LLD AS IT WAS LIKELY THE MECHANISM OF INJURY AS IT WAS THE TRACTION PLATFORM USED WHEN THE INJURY OCCURRED AT THE IMPLANT SITE OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220869 SPECTRANETICS LEAD LOCKING DEVICE LLD DRB SPECTRANETICS 518-062 FLP15J02A

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| L| R