BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2617896 · Received June 15, 2012

    Report

    Report Number
    1721279-2012-00061
    Event Type
    Injury
    Date Received
    June 15, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 16, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CARDIAC LEAD EXTRACTION CASE PERFORMED IN THE OR TO REMOVE TWO LEADS (RA, VITATRON (B)(4), IMPLANTED 2001, AND RV, VITATRON (B)(4), IMPLANTED 1985) DUE TO INFECTION. AN ARTERIAL LINE WAS PLACED AND TEE AND FLUOROSCOPY WERE USED THROUGHOUT THE CASE. A CT SURGEON WAS SCRUBBED INTO THE CASE. EACH LEAD WAS PREPPED WITH AN LLD #2, AND A 14F SLS II WAS USED. THE RA LEAD WAS REMOVED USING THE SLS, AND A TAMPONADE WAS IMMEDIATELY NOTED (BLOOD PRESSURE DROPPED AND PERICARDIAL FLUID INCREASED). THE CT SURGEON PERFORMED A STERNOTOMY AND A TEAR WAS IDENTIFIED AND REPAIRED IN THE SVC/ATRIAL JUNCTION. THE RV LEAD WAS THEN REMOVED USING THE SLS, BUT AGAIN BLEEDING OCCURRED AT THE SVC/ATRIAL JUNCTION. THE CT SURGEON IDENTIFIED AND REPAIRED A SECOND TEAR IN THE SVC/ATRIAL JUNCTION. THE PATIENT WAS STABILIZED AND SENT TO INTENSIVE CARE DEPARTMENT. NO DEVICE WAS RETURNED FOR ENGINEERING INSPECTION. THERE WERE NO ISSUES OR NONCONFORMANCES NOTED DURING AN INTERNAL LOT HISTORY REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 14 F SLS II MFA SPECTRANETICS CORPORATION 500-012 FJJ11J29E

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R MDT VITATRON (B)(4) RA LEAD| MDT VITATRON (B)(4) RV LEAD| LLD #2| CVX-300 EXCIMER LASER SN (B)(4)