BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH

    MDR report key: 1575092 · Received January 8, 2010

    Report

    Report Number
    1721279-2009-00064
    Event Type
    Death
    Date Received
    January 8, 2010
    Date of Event
    December 24, 2009
    Report Date
    January 7, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATES FOR ALL DEVICES: UNK.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: ICD LEAD FRACTURE. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE PERFORMED IN THE LAB, 1 LEAD TO BE REMOVED (ACTIVE RV LEAD, IMPLANTED IN 2004). THIRTY MINUTES INTO THE PROCEDURE, THE MD WAS HAVING DIFFICULTY ADVANCING THE 16F SLS FROM THE SVC TO THE RA DUE TO THE AREA BEING HIGHLY FIBROSED. THE MD WAS ABLE TO SUCCESSFULLY PASS THIS AREA BUT FELT THE LEAD "POP". THE PATIENT'S VITAL SIGNS WERE WITHOUT CHANGE, BUT THE MD ORDERED A STAT FLUOROSCOPY TO VISUALIZE THE PATIENT'S HEART AND LUNGS. A CARDIAC TAMPONADE WAS SEEN AND THE PATIENT'S HEART RATE BEGAN DECREASING. THE CT SURGEON WAS CONTACTED, A STERNOTOMY PERFORMED AND A "4 INCH SVC TEAR" DISCOVERED. ANALYSIS: THE DEVICES USED IN THIS CASE WERE NOT RETAINED BY THE HOSPITAL STAFF FOR POST-PROCEDURE ANALYSIS BY THE MANUFACTURER. LOT HISTORY REVIEWS WERE UNABLE TO BE PERFORMED SECONDARY TO DEVICES BEING DISPOSED OF AND HOSPITAL STAFF DID NOT RECORD THIS INFORMATION. PATIENT'S OUTCOME: THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death LLD (UNK SIZE/LOT)| GENERATION 4 EXCIMER LASER