BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 3042337 · Received April 9, 2013

    Report

    Report Number
    1721279-2013-00048
    Event Type
    Death
    Date Received
    April 9, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CARDIAC LEAD EXTRACTION CASE PERFORMED IN THE OR TO REMOVE 3 LEADS (RV-MEDTRONIC 4504, IMPLANTED (B)(6) 2000; (B)(4), IMPLANTED (B)(6) 1987; (B)(4), IMPLANTED (B)(6) 1990) DUE TO INFECTION AND ENDOCARDITIS. THE EXTRACTION WAS EXTREMELY DIFFICULT AND INVOLVED A MULTI-MODALITY APPROACH. ALL LEADS WERE PREPPED WITH AN LLD-EZ. THE PHYSICIAN BEGAN WITH A 14F GLIDELIGHT LASER SHEATH ON ONE OF THE RA LEADS. SEVERE BINDING WAS ENCOUNTERED, AND THE LASER SHEATH COULD NOT ADVANCE. THE PHYSICIAN SWITCHED TO THE SECOND RA LEAD, UPSIZING TO A 16F GLIDELIGHT. AFTER SOME ADVANCEMENT, HE ENCOUNTERED AN OBSTRUCTION AND WAS UNABLE TO ADVANCE. THE LOCATION OF THE OBSTRUCTION WAS THE SVC/ RA JUNCTION. THE LEAD BEGAN TO FALL APART, SO THE PHYSICIAN SWITCHED TO THE RV LEAD. THE 16F GLIDELIGHT ADVANCED ALL THE WAY TO THE DISTAL COIL. SEVERE BINDING WAS NOTED AT THE SVC/RA JUNCTION, BUT THE LASER WAS ABLE TO ADVANCE. SEVERE BINDING WAS AGAIN ENCOUNTERED. WITH ADEQUATE TRACTION AND APPROPRIATE FORCE, THE LASER SHEATH ADVANCED ALL THE WAY TO THE DISTAL TIP OF THE LEAD, WHERE THE VERY TIP OF THE LEAD BROKE. THE LEAD WAS EXTRACTED AND REMNANT OF THE LEAD TIP WAS LEFT IN PLACE. THE PHYSICIAN THEN RETURNED TO THE SECOND RA LEAD. HE UTILIZED A NEW 16F GLIDELIGHT SHEATH. HE ADVANCED TO THE SVC/RA JUNCTION AND ENCOUNTERED SEVERE BINDING AGAIN. AFTER SEVERAL TRAINS WITH THE LASER, THE PATIENT'S PRESSURE DIPPED AND AN EFFUSION WAS NOTED ON ECHO. A PERICARDIOCENTESIS WAS PERFORMED WHILE THE CT SURGEON WAS CALLED. THE CT THEN PERFORMED A SUB-ZYPHOID AND DRAINED THE REMAINING BLOOD FROM THE PERICARDIUM. ECHO IDENTIFIED NORMAL LV AND HEART FUNCTION. THE PATIENT WAS STABILIZED AND THE EXTRACTION RESUMED. UTILIZING A NEW 14F GLIDELIGHT, THE PHYSICIAN ATTEMPTED TO REMOVE THE FIRST RA LEAD. HE ADVANCED THE LASER SHEATH DISTAL OF THE SVC/RA JUNCTION. SEVERE BINDING WAS AGAIN ENCOUNTERED. THE PHYSICIAN WITHDREW THE LASER SHEATH AND EMPLOYED A COOK 9F EVOLUTION ON THE UNBROKEN RA LEAD. THE EVOLUTION PROGRESSED TO THE SVC/RA JUNCTION AREA, WHERE AN OBSTRUCTION WAS ENCOUNTERED. PROGRESSION STALLED AND ANOTHER EFFUSION WAS LOCATED ON ECHO. THE PATIENT'S BP BEGAN TO DROP AGAIN. THE CT RE-OPENED THE SUB-ZYPHOID INCISION AND TRIED TO DRAIN THE EFFUSION IN THAT MANNER. THIS WAS UNSUCCESSFUL. A STERNOTOMY WAS PERFORMED AND AN SVC TEAR WAS IDENTIFIED. THE CT ORDERED THE PATIENT BE PLACED ON BY-PASS, BUT THE BY-PASS WAS UNSUCCESSFUL. THE CT SURGEON STOPPED AND CALLED AN END TO THE PROCEDURE. THE PATIENT HAD EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147687 SPECTRANETICS GLIDELIGHT LASER SHEATH 16 F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 FGC13A14E

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death MEDTRONIC 4504 LEAD| SJM 240-G LEAD| SJM 329-258 LEAD| LLD-EZ (4 EACH)| 14F GLIDELIGHT| 16F GLIDELIGHT| 9F COOK EVOLUTION| CVX-300 EXCIMER LASER