BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1932718 · Received December 2, 2010

    Report

    Report Number
    1721279-2009-00019
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    March 6, 2009
    Report Date
    March 23, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVICES RETURNED FOR ENGINEERING ANALYSIS. THE RESULTS OF AN INTERNAL DEVICE LOT HISTORY REVIEW FOUND NO ISSUES.

    Description of Event or Problem · 1

    IN RESPONSE TO FORM (B)(4) ISSUED TO SPECTRANETICS ON 11/05/2010, OBSERVATION #2, ALL VIGILANCE REPORTS FILED, WILL ALSO BE FILED WITH THE FDA FOR ALL SAME/LIKE DEVICES SOLD IN THE UNITED STATES. THIS AE WAS ORIGINALLY FILED WITH THE CA ON 06/22/2009. ON (B)(6) 2009, A PT OF UNK AGE, GENDER OR WEIGHT UNDERWENT AN EX-PLANTATION OF 1 ATRIAL AND 2 VENTRICULAR ICD LEADS. THE PHYSICIAN PREPPED THE LEADS WITH A LLD#2 AND LASED WITH THE 16F SLS. THE REMOVAL OF THE ATRIAL AND THE FIRST VENTRICULAR LEAD WERE UNCOMPLICATED. DURING THE EXTRACTION OF THE SECOND VENTRICULAR LEAD, IT WAS NOTED THE PT BEGAN SHOWING SIGNS OF CARDIOGENIC SHOCK. THE PHYSICIAN NOTED A PERICARDIAL TAMPONADE AND PERFORMED A SUCCESSFUL PUNCTURE OF THE PERICARDIUM AND RESTORED CIRCULATION. ON (B)(6) 2009, THE PT SHOWED SIGNS OF BLOOD LOSS AND REQUIRED A BLOOD TRANSFUSION. CAT SCAN SHOWED A RIGHT HEMOTHORAX WITH SUSPICION OF A MYOCARDIAL BLEED. AN EMERGENT STERNOTOMY WAS PERFORMED AND A 5CM RUPTURE OF THE LATERAL WALL OF THE SVC WAS FOUND. DR (B)(6) DOCUMENTED IN THE FINAL REPORT: "CAUSE OF DEATH WAS MULTIPLE ORGAN FAILURE BECAUSE OF HEMORRHAGIC SHOCK AFTER INJURY OF THE SVC ..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORP. 500-013 C08K08A09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death LLD#2 (518-019/CLL08H12B)| CVX-300 EXCIMER LASER (B)(4)