BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 3010566 · Received March 19, 2013

    Report

    Report Number
    1721279-2013-00029
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE OR TO REMOVE ONE INFECTED LEAD. THE LEAD WAS PREPPED WITH AN LLD-EZ AND PLACED TO THE TIP OF THE LEAD. A 14F GL WITH 33CM MEDIUM VISISHEATH WAS CALIBRATED AND PLACED OVER THE RV LEAD ((B)(4)). THE 14F GL AND WAS ABLE TO GET TO THE SVC JUNCTION AND HALF WAY OVER THE SVC COIL WITHOUT ADVANCING ANY FURTHER. AFTER TWO LASER TRAINS, THE PHYSICIAN WAS UNABLE TO PROGRESS PAST THIS BINDING SITE, SO THE PHYSICIAN UPSIZED TO A 16F GL WITHOUT AN OUTER SHEATH. THE 16F GL WAS ABLE TO LASE OVER THE REST OF THE SVC COIL. ONCE AT THE SVC/ATRIAL JUNCTION, A DROP IN PRESSURE WAS NOTED, SO THE SURGEON WAS CALLED. ECHO SHOWED EFFUSION GROWING IN SIZE, APPROXIMATELY 2CM ACCORDING TO ANESTHESIA. EPPY WAS GIVEN AND A PERICARDIOCENTESIS WAS PERFORMED. TWO UNITS OF BLOOD WERE GIVEN THROUGH THE FEMORAL VENOUS SHEATH. THE EFFUSION WAS NOT GROWING IN SIZE WITH PERICARDIAL DRAIN IN PLACE. A THIRD UNIT OF BLOOD WAS STARTED, AND THEY WERE STILL TRYING TO CONTROL WITH PERICARDIOCENTESIS. PATIENT WAS STABLE, PHYSICIAN DECIDED TO CONTINUE TO LASE WITH 16F SHEATH, BUT WAS UNABLE TO LASE THROUGH THE BINDING SITE AT THE LATERAL WALL OF THE ATRIUM. FIRM TRACTION ON THE LEAD WOULD NOT STRAIGHTEN OUT THE LEAD. LASER DISCONTINUED AND SHEATH WAS SLOWLY REMOVED. BECAUSE THE PATIENT WAS STABLE, DECIDED TO LEAVE PERICARDIOCENTESIS NEEDLE/LINE IN PATIENT AND MOVE TO (B)(6). PATIENT WILL COME BACK TO SURGERY IN 3-5 DAYS TO PERFORM PARTIAL STERNOTOMY TO REMOVE THE LEAD. NO DEVICES WERE RETURNED FOR ENGINEERING EVALUATION. THERE WERE NO ISSUES OR NONCONFORMANCES NOTED DURING THE INTERNAL LOT HISTORY REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113308 SPECTRANETICS GLIDELIGHT LASER SHEATH 16F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 FGC13A29K

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R LLD-EZ| CVX300 EXCIMER LASER (SN (B)(4))| VISISHEATH, SIZE M ((MEDIUM)| MEDTRONIC 6949 LEAD| 14F GLIDELIGHT LASER SHEATH