BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH

    MDR report key: 2814741 · Received February 2, 2010

    Report

    Report Number
    1721279-2009-00067
    Event Type
    Death
    Date Received
    February 2, 2010
    Date of Event
    December 30, 2009
    Report Date
    February 1, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: UNKNOWN. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE PERFORMED IN THE CATH LAB. THE LEAD EXTRACTION WAS REPORTEDLY DECIDED UPON DURING THE CASE. THE PHYSICIAN CHOSE TO EXTRACT AN OLD, CAPPED GUIDANT (NOT IN GUIDANT DATABASE) LEAD. THE MD BEGAN LASING WITH THE 14F SLS, THEN UP-SIZED TO THE 16F IN CONJUNCTION WITH A COOK LIBERATOR LOCKING STYLET. THE MD NOTED THE PATIENT'S BLOOD PRESSURE DROPPING DURING THE EXTRACTION, AN EMERGENT THORACOTOMY WAS PERFORMED AND THE INJURY SITE WAS FOUND AT THE SVC. SPNC WAS NOTIFIED SEVERAL DAYS AFTER THE EVENT. ANALYSIS: LOT HISTORY REVIEWS WERE UNABLE TO BE PERFORMED SECONDARY TO THE DEVICES BEING DISCARDED DURING THE CODE. PATIENT OUTCOME: THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH 16F AND 14F SLS MFA SPECTRANETICS CORP. 500-012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death GENERATION 4 EXCIMER LASER| COOK LIBERATOR LOCKING STYLET