BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISISHEATH DILATOR SHEATH

    MDR report key: 2103996 · Received April 12, 2011

    Report

    Report Number
    1721279-2011-00026
    Event Type
    Death
    Date Received
    April 12, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DRE
    PMA / PMN Number
    K092378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CARDIAC LEAD EXTRACTION CASE CONDUCTED IN THE HYBRID SUITE OF THE OPERATING ROOM WITH INTENT OF REPLACING A MALFUNCTIONING RA LEAD. THE MD PREPARED THE RA LEAD WITH AN LLD-EZ AND BEGAN LASING WITH THE 14F SLS, IN ADDITION TO A MEDIUM 33CM VISISHEATH. WHEN ATTEMPTING TO PASS AN OCCLUSION WITH THE VISISHEATH IN THE SVC/RA JUNCTION, A SVC TEAR WAS CONFIRMED VIA FLUOROSCOPY. THE PATIENT'S ARTERIAL BLOOD PRESSURE DROPPED, THE CT SURGEON WAS PAGED, AN EMERGENT PERICARDIOCENTESIS WAS PERFORMED, CPR STARTED. THE CRASH CART CONTAINING THE THORACOTOMY AND OPEN CHEST TRAY WAS NOT IN THE HYBRID SUITE, BUT OUT IN THE HALLWAY. TWENTY-FIVE MINUTES LATER CPR STILL IN PROGRESS, THE CT SURGEON ARRIVED AND PERFORMED A THORACOTOMY APPROXIMATELY 5 MINUTES LATER. A TEAR IN THE SVC/ARTERIAL JUNCTION WAS NOTED, BUT UNFORTUNATELY THE PATIENT WAS UNABLE TO RECOVER AT THAT POINT. NO DEVICES WERE RETAINED FOR RETURN ANALYSIS, AS THEY WERE DISCARDED DURING THE CODE. SEVERAL (04/25/2011, 05/09/2011 AND 05/10/2011) UNSUCCESSFUL ATTEMPTS WERE MADE TO GATHER DEVICE LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISHEATH DILATOR SHEATH 14F VISISHEATH M 33CM DRE SPECTRANETICS CORP. 501-114 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death LLD-EZ: 518-062| CVX-300 EXCIMER LASER: SERIAL# (B)(4)| 14F SLS II: 500-012