BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY LONG

    MDR report key: 1241806 · Received November 18, 2008

    Report

    Report Number
    9616666-2008-00002
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Report Date
    November 14, 2008
    Manufacturer
    CLEAR STREAM
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD FOR LOT 599038 WAS REVIEWED, AND ALL TESTING DATA WHICH WAS NOTED AT THE TIME OF MANUFACTURING WAS WITHIN SPECIFICATION, AND NO ANOMALIES WERE NOTED. THE ASSOCIATED PRODUCT WAS UNAVAILABLE FOR RETURN FOR INVESTIGATION. WE HAVE REVIEWED THE COMPLAINT DATA FOR THIS AND RELATED PRODUCTS, AND THIS IS THE FIRST INSTANCE OF THIS TYPE OF PROBLEM THAT WE HAVE HAD IN RELATION TO THE SAVVY LONG RANGE THAT WE HAVE BEEN NOTIFIED ABOUT. IF THE PRODUCT BECOMES AVAILABLE IN THE FUTURE OR IF ANY SIMILAR COMPLAINTS ARE RECEIVED, WE WILL REOPEN THIS COMPLAINT AND COMPLETE A FULL INVESTIGATION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    PRODUCT BECAME STUCK INSIDE THE INTRODUCER SHEATH DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY LONG PTA LIT CLEAR STREAM 436-5012S 599038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention