BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS 16F GLIDELIGHT LASER SHEATH

    MDR report key: 12308443 · Received August 11, 2021

    Report

    Report Number
    1721279-2021-00145
    Event Type
    Death
    Date Received
    August 11, 2021
    Date of Event
    June 30, 2021
    Report Date
    July 14, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHILIPS REPRESENTATIVE BECAME AWARE OF A LEAD EXTRACTION PROCEDURE THAT COMMENCED ON (B)(6) 2021, FOR UNKNOWN INDICATION. THEY WERE EXTRACTING LEADS ON A (B)(6) YEAR OLD FEMALE. IT IS NOT KNOWN HOW MANY LEADS WERE BEING EXTRACTED, AND IT IS UNKNOWN THE LEAD MANUFACTURER OR MODEL. IT IS ALSO UNKNOWN WHAT TRACTION PLATFORM WAS USED DURING THE PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WAS IN USE, ALONG WITH A 14F GLIDELIGHT DEVICE AND A COOK MEDICAL EVOLUTION MECHANICAL DILATOR SHEATH. A SUPERIOR VENA CAVA (SVC) PERFORATION OCCURRED DURING THE PROCEDURE. A STERNOTOMY WAS PERFORMED, BUT DURING THE REPAIR OF THE VESSEL, MORE SHREDDING OF THE TISSUE OCCURRED WITH EVERY STITCH THE PHYSICIAN MADE. THE PATIENT DID NOT SURVIVE THE PROCEDURE. THE PHYSICIAN REPORTEDLY RETIRED THE DAY OF THE PROCEDURE AND NO FURTHER DETAIL WAS AVAILABLE FROM THE FACILITY. THIS REPORT CAPTURES THE 16F GLIDELIGHT IN USE AND AN SVC PERFORATION OCCURRED, RESULTING IN THE PATIENT'S DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205371 SPECTRANETICS 16F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-303 00813132020347

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death COOK MEDICAL EVOLUTION MECHANICAL DILATOR SHEATH| LEAD(S) MANUFACTURER AND MODEL UNK| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM