BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS 16F GLIDELIGHT LASER SHEATH

    MDR report key: 12334547 · Received August 17, 2021

    Report

    Report Number
    1721279-2021-00150
    Event Type
    Death
    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
    00813132020247
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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), RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD DUE TO POCKET EROSION. THIS WAS A RIGHT SIDED PROCEDURE. IT WAS REPORTED THAT THE LV LEAD WAS REMOVED SUCCESSFULLY WITH JUST TRACTION. THE RV LEAD WAS TARGETED NEXT, AND USING SPECTRANETICS 14F AND 16F GLIDELIGHT LASER SHEATHS, THE DEVICE ADVANCED THROUGH AN ADHESION AT APPROXIMATELY THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION AND THE PHYSICIAN SUCCESSFULLY EXTRACTED THE RV LEAD. THE LAST LEAD REMAINING WAS THE RA LEAD. USING THE 16F GLIDELIGHT DEVICE, THE PHYSICIAN LASED FOR APPROXIMATELY 10-15 SECONDS WHILE MANUALLY PUSHING THE GLIDELIGHT THROUGH THE ABOVE DESCRIBED ADHESION. THE ADHESION BROKE FREE AND THE GLIDELIGHT DEVICE MOVED FORWARD THROUGH THE SVC, UNENCUMBERED TO THE SVC/RA JUNCTION. AT THIS TIME, THE PATIENT'S BLOOD PRESSURE DROPPED VERY QUICKLY. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING CPR. THE PATIENT REQUIRED TRANSFER TO THE OR FOR FURTHER INTERVENTION. A STERNOTOMY WAS PERFORMED AND AN SVC PERFORATION WAS DISCOVERED; HOWEVER FURTHER INTERVENTIONS WERE UNSUCCESSFUL AND THE CARDIOVASCULAR SURGEON PRONOUNCED THE PATIENT DECEASED. THIS REPORT CAPTURES THE 16F GLIDELIGHT DEVICE IN USE AND AN SVC PERFORATION OCCURRED, REQUIRING INTERVENTION BUT RESULTED IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227208 SPECTRANETICS 16F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-303 FGC20F26A 00813132020247

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| R