BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1833054 · Received September 7, 2010

    Report

    Report Number
    1721279-2010-00054
    Event Type
    Death
    Date Received
    September 7, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (START OF CASE 1128) PROCEDURE INDICATION WAS TO REMOVE A MALFUNCTIONING ICD LEAD (RV LEAD, IMPLANTED 9 YRS PRIOR), TAKING PLACE IN THE CARDIAC CATHETER LAB. ARTERIAL LINE PLACED, RIGHT FEMORAL ARTERY ACCESS, POCKET OPENED, AND RV LEAD PREPPED FOR REMOVAL. AT (1140) ARTERIAL PRESSURE = 102/48, HR = 60. AT (1236) TEMPORARY PACING LEAD PLACED. AT (1302) MD ATTACHED THE LLD-EZ TO THE DISTAL TIP OF RV LEAD AND BEGAN LASING WITH A 16F SLS WITH THE ADDITION OF THE 16F VISISHEATH. AT (1308) EXTRACTION STARTED. AT (1445) ARTERIAL PRESSURE = 64/42, HR = 60. AT (1448) CPR STARTED, CT SURGEON NOTIFIED. AT (1308) ECHOCARDIOGRAM, CODE/CPR CONTINUED. AT (1345) CODE CALLED BY SURGEON, PT EXPIRED. THE SPNC DEVICES WERE DISPOSED OFF DURING THE CODE BY HOSPITAL STAFF. LHR REVIEW OF THE LLD-EZ (518-062/(B)(4)) REVEALED NO NON-CONFORMANCES OR ISSUES WITH THAT SPECIFIC LOT. GIVEN THAT THE LOT# FOR 16F SLS (500-013) IS UNK 3 LOTS (LOT# C10B22D) DELIVERED PRIOR TO THE (B)(6)2010 CASE DATE WERE REVIEWED. THERE WERE NO NON-CONFORMING MATERIALS OR ISSUES RELATED WITH THESE LOTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death VISISHEATH 16F (501-016/UNKNOWN SERIAL#)| CVX-300 EXCIMER LASER (B)(4)| LLD-EZ (518-062/FLD10B15A)