BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2230642 · Received August 12, 2011

    Report

    Report Number
    1721279-2011-00047
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SPECTRANETICS CORP
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT SIDED CARDIAC LEAD REMOVAL PROCEDURE OF A NON-FUNCTIONING RA LEAD. THE PT HAD A TOTAL OF 3 LEADS (RA, RV, AND LV; AGE 44MTHS; MODELS UNK). THE PROCEDURE WAS PERFORMED IN THE OPERATING ROOM WITH ARTERIAL LINE PLACEMENT, FLUOROSCOPY, AVAILABLE TEE, AND A CT SURGEON. THE MD BEGAN LASING THE RA LEAD WITH THE 14F SLS II. AFTER PASSING THE COIL AND ENTERING THE RIGHT ATRIUM, THE PT'S ARTERIAL BLOOD PRESSURE DROPPED DRAMATICALLY. AFTER VERIFICATION OF CARDIAC TAMPONADE BY TEE, AN EMERGENT STERNOTOMY WAS PERFORMED. THE SURGEON FOUND A TEAR IN THE DORSAL SVC. PT WAS PLACED ON BYPASS WITHIN 3 MINUTES. THE SVC TEAR WAS SUCCESSFULLY REPLACED WITH A PERICARDIAL PATCH, THE PT WAS DISCONNECTED FROM BYPASS AFTER 45 MINUTES, THE CHEST WAS CLOSED AND THE PT WAS TRANSFERRED TO ICU. THERE WERE NO DEVICES RETURNED FOR PRODUCT ANALYSIS. A LHR REVIEW WAS DONE AND FOUND NO ISSUES OR NON-CONFORMANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 14F SLS II MFA SPECTRANETICS CORP 500-012 CJJ11D06F

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R CVX-300 EXCIMER LASER (SERIAL# (B)(4))