BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2040835 · Received March 30, 2011

    Report

    Report Number
    1721279-2011-00016
    Event Type
    Death
    Date Received
    March 30, 2011
    Date of Event
    December 3, 2010
    Report Date
    March 9, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SPNC REPRESENTATIVE BECAME AWARE OF THE FOLLOWING CASE DURING A DISCUSSION WITH THE PHYSICIAN. THIS WAS A LEFT-SIDED, CARDIAC LEAD REMOVAL LEAD CASE CONDUCTED IN THE OPERATING ROOM TO REMOVE A (B)(6) OLD, FRACTURED ICD LEAD. BOTH ARTERIAL LINE PLACEMENT AND FLUOROSCOPY WERE UTILIZED DURING THE PROCEDURE. THE PHYSICIAN PREPPED THE POCKET, ATTACHED A LLD#2 TO THE DISTAL TIP OF EACH LEAD AND BEGAN LASING THE FRACTURED LEAD WITH THE 14F SLS II. AFTER THE MD UPSIZED TO THE 16F SLS THE PT'S ARTERIAL BLOOD PRESSURE TOOK A NOTABLE DECLINE. CHANGES WERE ALSO NOTED ON FLUOROSCOPY INDICATING A CARDIAC TAMPONADE. THE PT WAS PLACED ON CARDIAC BYPASS, AN EMERGENT STERNOTOMY PERFORMED, LACERATION OF THE INNOMINATE VEIN/SVC WAS DISCOVERED, AND SUCCESSFULLY REPAIRED. UNFORTUNATELY THE PT WAS UNABLE TO BE WEANED FROM BYPASS AND EXPIRED DUE TO COMPLICATIONS RELATED TO THE RESUSCITATION EFFORTS. AN INTERNAL LHR REVIEW REVEALED NO ISSUES OR NONCONFORMANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORP. 500-013 C09E20B

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death LLD #2 ((B)(4)/UNKNOWN LOT #)| CVX-300 EXCIMER LASER ((B)(4))| 14F SLS II ((B)(4))