BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS 16F GLIDELIGHT LASER SHEATH

    MDR report key: 12490536 · Received September 17, 2021

    Report

    Report Number
    1721279-2021-00175
    Event Type
    Death
    Date Received
    September 17, 2021
    Date of Event
    August 23, 2021
    Report Date
    August 23, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S DATE OF BIRTH UNK. PATIENT'S WEIGHT UNK. OTHER RELEVANT HISTORY UNK. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE ONE LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. USING A SPECTRANETICS LEAD LOCKING DEVICE (LLD) FOR TRACTION AND A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE PHYSICIAN WAS ABLE TO ADVANCE THE DEVICE TO THE UPPER SUPERIOR VENA CAVA (SVC). A TUNNEL-LIKE ADHESION WAS OBSERVED IN THE LOWER SVC, NEAR THE JUNCTION OF THE RIGHT ATRIUM (RA). WHEN LASING WAS PERFORMED, THE TIP OF THE LV LEAD COULD BE TAKEN INTO THE GLIDELIGHT LASER SHEATH. WHEN THE GLIDELIGHT DEVICE WAS REMOVED, THE PATIENT'S BLOOD PRESSURE DROPPED RAPIDLY. PERICARDIAL FLUID WAS NOT OBSERVED THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING THORACOTOMY. BLEEDING WAS CONFIRMED FROM THE SVC. REPAIR EFFORTS AND TREATMENT WERE PERFORMED BUT THE SHOCK CONDITION CONTINUED IN THE PATIENT, AND THE PATIENT DIED. THIS REPORT CAPTURES THE 16F GLIDELIGHT DEVICE IN USE WHEN THE SVC PERFORATION OCCURRED THAT REQUIRED INTERVENTION, BUT RESULTED IN PATIENT 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
    1386832 SPECTRANETICS 16F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-303 FGC21D27A 00813132020347

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death MEDTRONIC 5038S LV PACING LEAD| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICE