BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS 14F GLIDELIGHT LASER SHEATH

    MDR report key: 12334564 · Received August 17, 2021

    Report

    Report Number
    1721279-2021-00153
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 23, 2021
    Report Date
    July 23, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    UDI-DI
    00813132020330
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT UNAVAILABLE. OTHER RELEVANT HISTORY UNAVAILABLE. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA), A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD DUE TO INFECTION. BOTH THE RA AND THE LV LEADS WERE REMOVED WITHOUT COMPLICATION. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE RV LEAD USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH. HOWEVER, AFTER THE RV LEAD WAS REMOVED FROM THE BODY, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY AND BYPASS. A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED. THE REPAIR WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE AND AN SVC PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227476 SPECTRANETICS 14F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-302 FGB21A29A 00813132020330

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R