BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS 14F GLIDELIGHT LASER SHEATH

    MDR report key: 12222145 · Received July 23, 2021

    Report

    Report Number
    1721279-2021-00140
    Event Type
    Death
    Date Received
    July 23, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 28, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S DATE OF BIRTH UNAVAILABLE. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 1

    AN ELECTIVE LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. THE LEADS HAD BEEN IMPLANTED 11 YEARS. THE PHYSICIAN BEGAN ATTEMPT TO EXTRACT THE RV LEAD FIRST. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD, AND ALTHOUGH THE LLD COULD ONLY ADVANCE TO THE LEVEL OF THE TRICUSPID VALVE, THE PHYSICIAN USED THE LLD TO PROVIDE TRACTION TO AID IN THE LEAD'S EXTRACTION. USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE PHYSICIAN NOTED THAT THE RV AND RA LEADS WERE VERY ADHERENT TO EACH OTHER. THE PHYSICIAN SWITCHED DEVICES TO A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, BUT WITH THIS DEVICE WAS UNABLE TO GET PAST CLAVICULAR ADHESIONS, AS THE LEAD WAS TIGHTLY ENTWINED WITH THE RA LEAD. THE PHYSICIAN THEN DECIDED TO PREP THE RA LEAD FOR EXTRACTION, TO ALLOW RELEASE OF ADHESIONS AND ENABLE REMOVAL OF THE RV LEAD. AN LLD WAS INSERTED WITHIN THE RA LEAD, ABLE TO REACH THE LEAD'S DISTAL TIP. USING THE TIGHTRAIL SUB-C DEVICE, THE PHYSICIAN WAS ABLE TO GET PAST THE POINT OF THE PREVIOUS SUB-CLAVICULAR ADHESION AND REACHED THE LEVEL OF THE RA/SUPERIOR VENA CAVA (SVC) JUNCTION. THE PHYSICIAN SWITCHED BACK TO THE 14F GLIDELIGHT DEVICE. BOTH LEADS WERE CLOSELY ADHERENT TO EACH OTHER IN THE SVC REGION AS WELL. THE PHYSICIAN WAS ABLE TO LASE DOWN TO THE RA WITHOUT ANY HEMODYNAMIC CHANGES. UPON REMOVAL OF THE RA LEAD, A PERICARDIAL EFFUSION WAS NOTED AND THE PATIENT'S BLOOD PRESSURE STARTED TO DROP. RESCUE EFFORTS BEGAN IMMEDIATELY. THE EFFUSION APPEARED TO BE ENLARGING, SO THE TEAM PRESUMED THERE WAS A PERFORATION OF THE RA, AND FIRST ATTEMPTED A PERICARDIOCENTESIS. BECAUSE THE PATIENT WAS OBESE, IT REQUIRED AN EXTRA LONG NEEDLE AND ONLY A FEW ML OF BLOOD WERE ASPIRATED. THE PATIENT'S CONDITION SUGGESTED A CLOT IN THE PERICARDIAL SPACE, SO A STERNOTOMY WAS PERFORMED. AN SVC PERFORATION WAS DISCOVERED. VASCULAR REPAIR WAS SUCCESSFUL, AND THE RV LEAD WAS REMOVED AS WELL. THE PATIENT INITIALLY SURVIVED, BUT DIED EIGHT DAYS LATER WITH SEVERE NEUROLOGICAL DAMAGE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE GLIDELIGHT DEVICE USED IN THE SVC AREA DURING THE PROCEDURE AND AN SVC PERFORATION OCCURRED, AND THE PATIENT DIED EIGHT DAYS LATER. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118617 SPECTRANETICS 14F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-302 FGB21B05A 00813132020330

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death