BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1970064 · Received January 14, 2011

    Report

    Report Number
    1721279-2008-00037
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETAINED FOR RETURN ENGINEERING ANALYSIS, NOR WERE ANY ATTEMPTS AT GATHERING FURTHER CASE INFO SUCCESSFUL.

    Description of Event or Problem · 1

    IN RESPONSE TO FORM 483 ISSUED TO SPECTRANETICS ON (B)(6) 2010, OBSERVATION # 2, ALL VIGILANCE REPORTS FILED, WILL ALSO BE FILED WITH THE FDA FOR ALL SAME/LIKE DEVICES SOLD IN THE UNITED STATES. INDICATION FOR THIS CARDIAC LEAD REMOVAL WAS AN ACUTE POCKET INFECTION. THE PT HAD 2 ABANDONED LEADS THAT WERE CUT AFTER A FAILURE EXTRACTION ATTEMPT IN 2004. THE MD PREPPED THE RV LEAD WITH A LLD AND BEGAN LASING WITH THE 16F SLS. AGAIN, EXTRACTION WAS UNSUCCESSFUL AFTER SPENDING A REPORTED "LONG TIME LASING". THE MD THEN MOVED TO THE ATRIAL LEAD AND ATTEMPTED TO ATTACH THE LLD, BUT WAS UNABLE TO BECAUSE THE CARDIAC LEAD DID NOT HAVE A LUMEN. THE VENTRICULAR LEAD BROKEN WITH MINIMAL TRACTION ON THE LLD. THE MD DECIDED TO TAKE A FEMORAL APPROACH TO EXTRACT AND WAS ULTIMATELY SUCCESSFUL REMOVING BOTH THE ATRIAL AND VENTRICULAR LEADS. HOWEVER, THE TEE SHOWED BLEEDING IN THE PLACE THE ATRIAL LEAD WAS IMPLANTED. THE PT'S ARTERIAL BLOOD PRESSURE WAS DECLINING, THE PT WAS PREPPED TO GO INTO THE CARDIAC OPERATING ROOM. WELL OVER AN HOUR AFTER THE EXTRACTION THE CT SURGEON PERFORMED A STERNOTOMY, DISCOVERED A SVC PERFORATION, AND SUCCESSFULLY REPAIRED THE INJURY. THE PT SURVIVED THE SURGERY, BUT UNFORTUNATELY DIED SEVERAL DAYS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R CVX-300 EXCIMER LASER (B)(4)| LLD (UNK MODEL # / SERIAL #)