BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS 16F GLIDELIGHT LASER SHEATH

    MDR report key: 12417832 · Received September 2, 2021

    Report

    Report Number
    1721279-2021-00169
    Event Type
    Death
    Date Received
    September 2, 2021
    Date of Event
    August 13, 2021
    Report Date
    August 13, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    UDI-DI
    00813132020347
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT UNK. PATIENT'S ETHNICITY/RACE UNK. DEVICE LOT NUMBER, EXPIRATION DATE UNK. DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. DEVICE MANUFACTURE DATE UNK BECAUSE LOT NUMBER UNK.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. THE INFECTION HAD ERODED THE DEVICE OUTSIDE THE PATIENT'S CHEST. THE PATIENT WAS A (B)(6) FEMALE, POST BREAST CANCER, INCLUDING EXTENSIVE RADIATION TO THE CHEST AREA. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION TO AID IN THE EXTRACTIONS. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE PHYSICIAN ATTEMPTED TO ADVANCE THROUGH THE VASCULATURE. THE PHYSICIAN ENCOUNTERED STALLED PROGRESSION SO UPSIZED TO A 16F GLIDELIGHT DEVICE. AFTER LASING AND WHILE REMOVING THE RA LEAD WITH THE 16F GLIDELIGHT, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, SEVERAL UNITS OF BLOOD, STERNOTOMY AND BYPASS. THE TEAM DISCOVERED A TEAR FROM THE INNOMINATE VEIN, TO THE SUPERIOR VENA CAVA (SVC), AND TO THE SVC/RA JUNCTION. DUE TO THE EXTENSIVE RADIATION AND EXTREME CALCIFICATION OF THE PATIENT'S VEINS, THE REPAIR WAS EXTREMELY DIFFICULT, EVEN WITH 3 CT SURGEONS WORKING ON HER. ACCORDING TO THE CT SURGEON, ALL THE VEINS WITH TEARS WERE EXTREMELY BRITTLE, MAKING ANY SUTURING EXTREMELY TOUGH. THE PATIENT DID NOT SURVIVE THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT DEVICE IN USE WHEN THE INNOMINATE, SVC AND SVC/RA JUNCTION TEARS OCCURRED THAT REQUIRED INTERVENTION, BUT RESULTED IN PATIENT DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314077 SPECTRANETICS 16F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-303 00813132020347

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| R MEDTRONIC 4076 RA PACING LEAD| MEDTRONIC 6947 RV ICD LEAD| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICES