BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1962759 · Received January 13, 2011

    Report

    Report Number
    1721279-2010-00089
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS AN ELECTIVE RIGHT-SIDED, CARDIAC LEAD REMOVAL PROCEDURE CONDUCTED IN THE OPERATING ROOM WITH THE INTENT OF EXTRACTING 2 (RV AND RA; 15 YRS OLD) ABANDONED LEADS. THE LEADS WERE PREPPED AND A LLD-EZ WAS CONNECTED TO THE DISTAL END OF EACH CARDIAC LEAD. THE RV LEAD WAS PARTIALLY DISLODGED AND WAS EASILY REMOVED WITH THE LLD-EZ ONLY. THE MD THEN BEGAN LASING THE RA LEAD WITH THE 14F SLS, MEETING RESISTANCE IN THE SUBCLAVICULAR AREA THE MD UPSIZED TO THE 16F SLS AND THE LEAD WAS SUCCESSFULLY EXTRACTED. IMMEDIATELY PROCEEDING THE EXTRACTION THE PT'S ARTERIAL BLOOD PRESSURE DROPPED, A STAT TEE WAS PERFORMED SHOWING A SMALL EFFUSION. THE CT SURGEON PERFORMED AN EMERGENT STERNOTOMY AND SUCCESSFULLY REPAIRED A "THUMB-SIZED" HOLE IN THE PT'S RIGHT ATRIUM. THE PT STABILIZED, TRANSFERRED TO THE ICU AND WAS DISCHARGED HOME ONE WEEK LATER. NO DEVICES WERE RETAINED FOR RETURN ENGINEERING ANALYSIS, AS THEY WERE DISPOSED OFF DURING THE CODE. SEVERAL UNSUCCESSFUL ATTEMPTS (B)(4) WERE MADE TO GAIN FURTHER DEVICE INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention LLD-EZ ((B)(4)/UNK LOT#)| CVX-300 EXCIMER LASER (SERIAL# (B)(4))| 14F SLS ((B)(4)/UNK LOT#)