BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD LOCKING DEVICE

    MDR report key: 2902390 · Received January 8, 2013

    Report

    Report Number
    1721279-2012-00190
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN THE O.R. AND THE PATIENT WAS PREPPED PER HRS RECOMMENDED GUIDELINES. THE MD APPROPRIATELY PREPPED THE LEAD AND EMPLOYED AN LLD-EZ AND UTILIZED A 14F GLIDELIGHT LASER SHEATH AND ONCE UNDER THE CLAVICLE, SIGNIFICANT LEAD ON LEAD BINDING WAS ENCOUNTERED. THE LASER SHEATH WAS ABLE TO ADVANCE FLUIDLY. MD APPLIED THE APPROPRIATE AMOUNT OF TRACTION AS HE ADVANCED THE LASER SHEATH PAST THE SVC AND INTO THE RV. ONCE IN THE RV, IT WAS NOTED THAT THE RA LEAD (5076) HAD BEEN PULLED OUT OF PLACE. THE SCREW WAS LOCATED NEXT TO THE LASER SHEATH (WHICH WAS IN THE RV AT THIS POINT). IT APPEARED AS THOUGH THE LEAD ON LEAD BINDING CAUSED THE ATRIAL LEAD TO DISLODGE AS THE LASER SHEATH WAS ADVANCED. NO DROP IN ABP WAS NOTED. THE GLIDELIGHT WAS ADVANCED TO WITHIN A CENTIMETER OF THE SCREW ON THE 6949 AND LASING WAS STOPPED. TRACTION WAS HELD UNTIL THE LEAD DISLODGED AND IT WAS REMOVED. UPON REMOVAL, THE PATIENT'S ABP DROPPED INTO THE 40'S WHERE IT HELD CONSTANT. TAMPONADE WAS IDENTIFIED. CVS WAS CALLED AND WERE IN THE ROOM WITH IN ONE MIN. TIME TO INTERVENTION WAS APPROXIMATELY 2-3MINS. AN EMERGENT STERNOTOMY WAS PERFORMED AND THE PATIENT PLACED ON BYPASS DURING THE REPAIR. A 5-7MM PERFORATION WAS IDENTIFIED IN THE RA AND SUCCESSFULLY REPAIRED. ONCE PATIENT WAS STABLE, THE RA LEAD WAS REMOVED WITH STEADY TRACTION AND AN LLD-EZ. AS OF (B)(6) 2012 THE PATIENT WAS EXTUBATED AS IS SAID TO HAVE MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9100 LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 FLP12G16A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R MDT 6949| 14F GLIDELIGHT| MDT 5076| CVX-300 EXCIMER LASER