BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP RETRIEVAL BASKET

    MDR report key: 773475 · Received October 25, 2006

    Report

    Report Number
    6000043-2006-00122
    Event Type
    Injury
    Date Received
    October 25, 2006
    Date of Event
    October 3, 2006
    Report Date
    October 12, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER. WITHOUT THE DEVICE AND WITHOUT FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS EVENT. OUR DIRECTIONS FOR USE STATE: "CAUTION: IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE, DO NOT EXERT EXCESSIVE FORCE".

    Description of Event or Problem · 1

    IT WAS REPORTED THE BASKET OF THIS STONE RETRIEVAL DEVICE DETACHED IN THE PATIENT DURING A THERAPEUTIC STONE RETRIEVAL PROCEDURE. NO PATIENT SEQUELEA RESULTED FROM THIS EVENT. NO FURTHER INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT OR RETRIEVAL DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP RETRIEVAL BASKET STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC NA 5114627

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention