BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1910661 · Received November 22, 2010

    Report

    Report Number
    1721279-2010-00072
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED, CARDIAC LEAD REMOVAL PROCEDURE CONDUCTED IN THE OPERATING ROOM WITH BOTH ARTERIAL LINE PLACED AND ACTIVE FLUOROSCOPY THROUGHOUT THE PROCEDURE. THE PACEMAKER WAS REMOVED AND REVISION OF POCKET COMPLETED. THE MD STARTED WITH THE LV LEAD AND IT REMOVED WITH STYLET ONLY. NEXT, THE RV LEAD WAS REMOVED WITH LLD-EZ AND TRACTION ONLY. THE BI-V ICD LEAD WAS PREPPED AND LOCKED DOWN WITH LLD-EZ WITHOUT INCIDENT. THE MD THEN BEGAN LASING WITH THE 16F SLS, EXTRACTING THE LEAD AND ADVANCING TO THE DISTAL COIL WITHOUT INCIDENT. THE LEAD POPPED FREE FROM THE MYOCARDIUM ABRUPTLY FROM THE TENSION ON THE LEAD. PT WAS MONITORED FOR SEVERAL MINS TO ENSURE THERE WERE NO PROBLEMS CAUSED BY THIS. CASE WAS COMPLETED AND PT WAS DOING FINE IN RECOVERY WHILE THE MD FINISHED DICTATING. IT WAS AT THIS TIME, A SIGNIFICANT DROP IN ARTERIAL BLOOD PRESSURE WAS NOTED BY ANESTHESIA, AND A TEE CONFIRMED A PERICARDIAL EFFUSION. THE MD PERFORMED A PERICARDIOCENTESIS, BUT WAS UNABLE TO EXTRACT ANY FLUID. THE CT SURGEON WAS CALLED AND A SUB-XIPHOID WINDOW WAS PERFORMED TO FIND NO PERFORATION BUT A LOT OF CLOTTED BLOOD IN THE PERICARDIAL SAC. CLOTS WERE REMOVED AND A DRAIN WAS PLACED. PT WAS TRANSFERRED TO THE ICU WITHOUT FURTHER INCIDENT. DR (B)(6) FELT THE PERICARDIAL ABNORMALITY HAD NOTHING TO DO WITH THE LASER OR SPNC DEVICES UTILIZED DURING THE CASE. THERE WERE NO DEVICES RETAINED FOR RETURN ENGINEERING ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention LLD-EZ (518-062/UNKNOWN SERIAL#)| CVX-300 EXCIMER LASER (B)(4)