BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 12368650 · Received August 25, 2021

    Report

    Report Number
    1721279-2021-00163
    Event Type
    Death
    Date Received
    August 25, 2021
    Date of Event
    July 29, 2021
    Report Date
    August 10, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LIMITED INFORMATION WAS PROVIDED TO THE REPRESENTATIVE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. PATIENT INFORMATION: UNK. RELEVANT TESTS/LABORATORY DATA :UNK. OTHER RELEVANT HISTORY : UNK. DEVICE MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE AND UDI: 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 PHILIPS REPRESENTATIVE BECAME AWARE ON 10 AUG 2021 THAT A LEAD EXTRACTION PROCEDURE COMMENCED ON (B)(6) 2021. TWO LEADS WERE PRESENT WITHIN THE PATIENT, A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD. DURING USE OF A LASER (THE FACILITY STOCKS SPECTRANETICS GLIDELIGHT LASER SHEATHS), A SUPERIOR VENA CAVA (SVC) PERFORATION OCCURRED. TAMPONADE RESULTED. RESCUE EFFORTS BEGAN, INCLUDING CHEST COMPRESSIONS AND STERNOTOMY. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE THE RESCUE EFFORTS. THIS REPORT CAPTURES THE GLIDELIGHT DEVICE IN USE WHEN AN SVC PERFORATION OCCURRED, REQUIRING INTERVENTION AND RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265542 SPECTRANETICS GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R