BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14FR SPECTRANETICS LASER SHEATH II

    MDR report key: 2718208 · Received August 28, 2012

    Report

    Report Number
    1721279-2012-00096
    Event Type
    Injury
    Date Received
    August 28, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 7, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CARDIAC LEAD EXTRACTION CASE CONDUCTED IN THE EP LAB TO REMOVE THE SYSTEM AS IT WAS NO LONGER REQUIRED (GDT 4087-RA AND SJM 1580 ICD LEAD-RV). LEADS WERE EACH PREPARED WITH AN LLD-EZ, AND A 14FR SLS II WAS UTILIZED. THE SJM 1580 WAS REMOVED SUCCESSFULLY, ALTHOUGH THERE WAS A DIP IN THE BLOOD PRESSURE. THE SURGEON AND AN ECHO WERE BROUGHT IN AND NO INJURY WAS IDENTIFIED. THE EXTRACTION OF THE GDT 4087 WITH THE 14FR SLS II WAS INITIATED, BUT THERE WAS AN IMMEDIATE DROP IN BLOOD PRESSURE. THE SURGEON OPENED THE CHEST WITHIN 5 MINUTES. A SMALL SVC TEAR WAS IDENTIFIED AND REPAIRED WITH STITCHES. THE GDT 4087 WAS REMOVED DURING THE STERNOTOMY. PATIENT HAS ALREADY BEEN DISCHARGED FROM THE HOSPITAL AND IS DOING FINE. NO DEVICE WAS RECEIVED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED, SO NO INTERNAL LOT HISTORY REVIEW COULD BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14FR SPECTRANETICS LASER SHEATH II 14FR SLS II MFA SPECTRANETICS CORPORATION 500-012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R SJM 1580 LEAD| GDT 4087 LEAD| LLD-EZ (2 EACH)| CVX-300 EXCIMER LASER (SN (B)(4))