BEUDAMED
    FDA Adverse Event Other Summary report: N

    PFST-SWRTZ STONE RETRIEVER, 4FR

    MDR report key: 604116 · Received May 20, 2005

    Report

    Report Number
    1423507-2005-00071
    Event Type
    Other
    Date Received
    May 20, 2005
    Date of Event
    March 3, 2005
    Report Date
    May 20, 2005
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WIRE ATTACHED TO BASKET TO PULL BASKET OUT DETACHED FROM BASKET. ADDITIONALLY, THE ACCOUNT STATED THAT A PATIENT CAME IN TO HAVE STONES REMOVED. DURING THE PROCEDURE, THE PHYSICIAN PULLED ON THE STONE RETRIEVER TO REMOVE THE STONE, BUT THE STONE WAS TOO BIG AND THE BASKET BROKE. THE PIECE THAT BROKE OFF WAS LEFT INSIDE THE PATIENT. THE BASKET WAS PERCUTANEOUSLY REMOVED FROM THE PATIENT IN RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFST-SWRTZ STONE RETRIEVER, 4FR STONE RETRIEVER FFL CARDINAL HEALTH GU6358 1041049

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R