BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLS II

    MDR report key: 1071466 · Received June 19, 2008

    Report

    Report Number
    1721279-2008-00013
    Event Type
    Death
    Date Received
    June 19, 2008
    Date of Event
    March 24, 2008
    Report Date
    June 10, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INDICATION FOR LEAD REMOVAL: INFECTED ICD LEAD (MODEL 6947) THAT HAD BEEN IMPLANTED FOR 7 YEARS. PROCEDURE: THE LEAD REMOVAL WAS A LEFT SIDED REMOVAL, USING A 16 FR SLS USING THE OUTER SHEATH. THE CATHETER WAS ADVANCING DOWN THE LEAD, THROUGH HEAVY SCAR TISSUE. AT THE ATRIAL JUNCTION THE BP DROPPED AND AN ECHOCARDIOGRAM SHOWED A CARDIAC EFFUSION. THE PT WAS PREPPED AND TAKEN TO SURGERY. IN SURGERY, A TEAR IN THE SVC WAS FOUND, WHICH WAS THE CAUSE OF THE BP DROP. SURGICALLY, THE TEAR COULD NOT BE REPAIRED AND THE PT DIED DUE TO BLOOD LOSS. FLUORO AND ATRIAL MONITORING WERE USED THROUGHOUT THE PROCEDURE. AN AUTOPSY WAS NOT PERFORMED. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. THE PHYSICIAN STATED THAT THE EVENT WAS MOST LIKELY DUE TO THE NATURE OF THE PROCEDURE, INVOLVING A HEAVILY SCARRED LEAD AND VERY ILL PT. THIS REPORT WAS DELAYED WHILE OBTAINING DETAILS OF THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death SPECTRANETICS CVX-300 LASER