BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH / LEAD LOCKING DEVICE

    MDR report key: 1337486 · Received February 3, 2009

    Report

    Report Number
    1721279-2009-00007
    Event Type
    Death
    Date Received
    February 3, 2009
    Date of Event
    January 31, 2009
    Report Date
    January 31, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS: THE DEVICES WERE NOT RETAINED FOR RETURN. HOWEVER, THERE IS NO INDICATION THE SPNC DEVICES MALFUNCTIONED IN ANY WAY TO BE THE CAUSATIVE FACTOR IN THE INJURY/DEMISE OF THE PT.

    Description of Event or Problem · 1

    CLINICAL HISTORY: PT WAS A MALE WITH ACUTE SEPSIS SECONDARY TO POCKET INFECTION. PROCEDURE: PT HAD AN IMPLANTED BOSTON SCIENTIFIC PACEMAKER WITH 2 LEADS ON THE LEFT (NOT REMOVED), CAPPED LEADS ON THE RIGHT TO BE EXTRACTED: 6957 (ACTIVE FIXATION), IMPLANTED 1989, AND 487-02 (PASSIVE FIXATION) IMPLANTED 1989. THESE WERE BOTH 5-6MM LEADS. MD WAS UNABLE TO RETRACT THE HELIX ON THE ATRIAL LEAD AND USED A 16F SHEATH WITHOUT THE OUTER SHEATH TO EXTRACT THE A-LEAD FROM THE RIGHT SIDE. WHEN THE LEAD WAS FREED UP IN THE SVC, THE LEAD WAS FREE FLOATING IN THE HEART WITH A LARGE HELIX EXTENDED. THE ANESTHESIOLOGIST NOTED A DROP IN BLOOD PRESSURE, BEGAN INCREASING THE PT'S IV FLUID AND PLACED THE PT IN TRENDELENBURG POSITION. THE PT'S BLOOD PRESSURE APPEARED TO IMPROVE. MD LOADED #2LLD INTO V-LEAD, USED SHEATH AND BEGAN LASING THE POCKET, AND NOTED YET ANOTHER DROP IN THE PT'S PRESSURE. THE MD REMOVED THE SHEATH AND PROCEEDED TO CRACK THE PT'S CHEST DISCOVERING A SMALL TEAR IN THE SVC. THE PHYSICIAN WAS UNSUCCESSFUL AT REPAIRING THE TEAR. PT OUTCOME: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH / LEAD LOCKING DEVICE 16F SLS / LLD #2 MFA SPECTRANETICS CORP. 500-013 / 518-019 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death SPECTRANETICS CVX-300 LASER