BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1936084 · Received December 13, 2010

    Report

    Report Number
    1721279-2010-00082
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    SPECTRANETICS CORP
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS A RIGHT-SIDED CARDIAC LEAD REMOVAL CASE PERFORMED IN CV-OPERATING ROOM, WITH THE CV SURGEON SCRUBBED IN ALONG WITH THE EP. BOTH ARTERIAL LINE PLACEMENT AND FLUOROSCOPY WERE UTILIZED THROUGHOUT THE PROCEDURE. THE 10YR OLD PASSIVE RIGHT-SIDED IMPLANT WAS INFECTED WITH PASSIVE RA AND RV LEADS. THE MD CLEANED THE POCKET, REMOVED THE IMPLANT, PREPPED BOTH LEADS WITH THE LLD-EZ, AND BEGAN LASING WITH THE 14F SLS. THE RV LEAD WAS REMOVED WITHOUT DIFFICULTY. AFTER THE RA LEAD WAS REMOVED, THE PATIENT'S ARTERIAL BLOOD PRESSURE BEGAN TO DECLINE. THE CV SURGEON STEPPED IN IMMEDIATELY, PERFORMED A MEDICAL STERNOTOMY, BLOOD PRODUCTS WERE GIVEN, PERFORATION TO THE RA APPENDAGE WAS NOTED AND SUCCESSFULLY REPAIRED. PATIENT DID WELL AND REMAINED STABLE WITH NO FURTHER COMPLICATIONS. THERE WAS NO DEVICES RETAINED FOR RETURN ANALYSIS. ATTEMPTS (11-30, 12-1 & 12-3) WERE UNSUCCESSFUL AT OBTAINING FURTHER INFORMATION ABOUT THE DEVICE'S SERIAL/LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 14F SLS II MFA SPECTRANETICS CORP 500-012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention CVX-300 EXCIMER LASER (B)(4)| LLD-EZ (518-062/ UNK SERIAL #)