BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS 14F GLIDELIGHT LASER SHEATH

    MDR report key: 12555181 · Received September 30, 2021

    Report

    Report Number
    1721279-2021-00181
    Event Type
    Death
    Date Received
    September 30, 2021
    Date of Event
    September 7, 2021
    Report Date
    September 7, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT UNK. DEVICE LOT NUMBER, EXPIRATION DATE UNK. THE 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 THREE LEADS: A RIGHT ATRIAL (RA), A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA AND SEPTIC MRSA. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE RV LEAD WAS SUCCESSFULLY EXTRACTED. ATTEMPT TO REMOVE THE RA LEAD WAS NEXT. USING THE 14F GLIDELIGHT DEVICE, BINDING WAS NOTED AT THE INNOMINATE JUNCTURE AND SUPERIOR REGION OF THE SUPERIOR VENA CAVA (SVC). THE RA LEAD WAS EXTRACTED AND THE PATIENT'S ATRIAL PRESSURE BEGAN TO DROP SLOWLY. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED A GROWING PERICARDIAL EFFUSION. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON AND PERICARDIOCENTESIS. THE PATIENT'S PRESSURE ACUTELY ROSE AGAIN BUT REMAINED AT A LOW BASELINE (70¿S SYSTOLIC) BEFORE STARTING TO FALL AGAIN. A STERNOTOMY WAS PERFORMED AND THE CARDIOTHORACIC (CT) SURGEON DISCOVERED A PERFORATION IN THE INNOMINATE REGION AND SMALL PERFORATION IN RIGHT ATRIUM (ATRIAL PERFORATION CAPTURED IN MDR 1721279-2021-00182). THE LV LEAD WAS REMOVED SUCCESSFULLY AFTER STERNOTOMY VIA A TRANSVENOUS APPROACH. THE PATIENT DID NOT GO ON CARDIOPULMONARY BYPASS, THE PERFORATIONS WERE SUCCESSFULLY REPAIRED AND THE PATIENT INITIALLY SURVIVED THE PROCEDURE. HOWEVER, THE PHILIPS REPRESENTATIVE WAS INFORMED ON 14 SEPT 2021 THAT THE PATIENT DID NOT RECOVER FROM THE SURGERY AND PASSED AWAY ON (B)(6) 2021. THIS REPORT CAPTURES THE GLIDELIGHT DEVICE IN USE WHEN THE INNOMINATE PERFORATION OCCURRED, REQUIRING INTERVENTION, BUT ULTIMATELY 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
    1453660 SPECTRANETICS 14F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-302 00813132020330

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death MEDTRONIC 4196 LV LEAD| MEDTRONIC 5076 RA PACING LEAD| MEDTRONIC 6947 RV ICD LEAD| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICES