BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS 16F GLIDELIGHT LASER SHEATH

    MDR report key: 9935928 · Received April 8, 2020

    Report

    Report Number
    1721279-2020-00088
    Event Type
    Death
    Date Received
    April 8, 2020
    Date of Event
    March 17, 2020
    Report Date
    March 17, 2020
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    UDI-DI
    00813132020347
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT UNAVAILABLE.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. AN EXISTING LEFT VENTRICULAR (LV) LEAD WAS PRESENT IN THE PATIENT'S BODY AS WELL, BUT WAS NOT TARGETED FOR EXTRACTION. USING A SPECTRANETICS LEAD LOCKING DEVICE (LLD) AND A 14F GLIDELIGHT LASER SHEATH, THE PHYSICIAN ATTEMPTED TO EXTRACT THE RV LEAD FIRST. HE MET STALLED PROGRESSION, SO TURNED ATTENTION TO THE RA LEAD. PROGRESS ALMOST TO THE TIP OF THE RA LEAD WAS SUCCESSFUL; HOWEVER THE LEAD WAS NOT REMOVED. THE PHYSICIAN CHOSE TO UPSIZE TO A 16F GLIDELIGHT AND FOCUSED EFFORT AGAIN ON THE RV LEAD. SLOW STEADY PROGRESS WAS MADE TO THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION. THEY WERE THEN GOING TO GO BACK TO THE RA LEAD; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ACCUMULATION OF BLOOD WAS DETECTED IN THE PERICARDIAL SPACE. RESCUE EFFORTS WERE IMMEDIATE, INCLUDING RESCUE DEVICE AND CPR. A PERICARDIOCENTESIS WAS PERFORMED WITH 150CC BLOOD RETURN. THE PATIENT INITIALLY RECOVERED FOR A BIT, THEN THE BLOOD PRESSURE DROPPED AGAIN DESPITE USE OF PRESSORS. THE DECISION WAS THEN MADE TO PERFORM A STERNOTOMY. A SUPERIOR VENA CAVA (SVC) TEAR WAS DISCOVERED. REPAIR BEGAN TO THE TEAR; HOWEVER, THE PATIENT STARTED TO GO INTO VENTRICULAR TACHYCARDIA AND WAS SHOCKED SEVERAL TIMES IN THE RESCUE EFFORT. THEY CONTINUED RESCUE EFFORTS AFTER THE REPAIR WAS COMPLETE BUT THEY HAD DIFFICULTY STABILIZING THE PATIENT'S HEART RHYTHM. THE SURGEON ULTIMATELY STOPPED EFFORTS. THE PATIENT DIED. 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
    403529 SPECTRANETICS 16F GLIDELIGHT LASER SHEATH GLIDELIGHT MFA THE SPECTRANETICS CORPORATION 500-303 FGC19B04A 00813132020347

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death BOSTON SCIENTIFIC 0184 RV ICD LEAD| BOSTON SCIENTIFIC 4054 RA PACING LEAD| BOSTON SCIENTIFIC 4518 LV PACING LEAD| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICE