BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2404290 · Received January 5, 2012

    Report

    Report Number
    1721279-2011-00108
    Event Type
    Death
    Date Received
    January 5, 2012
    Date of Event
    December 9, 2011
    Report Date
    December 9, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE CONDUCTED IN THE EP LAB TO REMOVE A SJM 1580 RIATA LEAD THAT HAD EXTERNALIZED CONDUCTORS, AS IDENTIFIED UNDER FLUORO IN A (B)(6) FEMALE. THE CONDITION OF THE RV LEAD WORSENED AS A RESULT OF PREVIOUSLY EXTRACTING AN RA LEAD. AN ARTERIAL LINE WAS PLACED AND FLUOROSCOPY WAS AVAILABLE THROUGHOUT THE CASE. SURGICAL BACKUP AND A THORACOTOMY TRAY WERE AVAILABLE. THE EP PREPARED THE LEAD USING AN LLD-EZ. THE EXTRACTION BEGAN USING A 16F SLS. THE EXTRACTION OF RV ICD RIATA LEAD WAS SUCCESSFUL, AND THE LEAD WAS REMOVED INTACT. THE ARTERIAL PRESSURE JUST PRIOR TO REMOVAL AT 2:57 PM WAS 117/56. THE ARTERIAL PRESSURE DROPPED AFTER LEAD WAS REMOVED AT 2:58PM TO 104/48. THE 16FR SLSII WAS REMOVED FROM THE BODY AT 3:09 PM AND ARTERIAL PRESSURE WAS NOTED AT 45/-56. THE SURGEON WAS CALLED AND INTERVENED. THE CHEST WAS OPENED AT 3:37PM AND HIGH VOLUME BLOOD WAS NOTICED IN THE CHEST CAVITY. A "PALM" SIZED TEAR OF THE SVC AT THE AREA OF THE PROXIMAL COIL (AREA OF THE LATERAL SVC WALL) WAS NOTICED BY SURGEON. THE CARDIAC INTERVENTION ATTEMPT WAS STOPPED AND PATIENT EXPIRED AT 4:33PM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death CVX-300 EXCIMER LASER (SERIAL# (B)(4))| GDT SWEET TIP 4190| SJM 1580 RIATA LEAD| LLD-EZ (518-062)