BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 2111014 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01819
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS USED DURING A CYSTOSCOPY PROCEDURE (PATIENT IDENTIFIER AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT WAS UNDERGOING A CYSTOSCOPY, LEFT URETERAL STENT EXCHANGE, LEFT URETEROSCOPY, LASER LITHOTOPSY AND LEFT STONE BASKET EXTRACTION DUE TO LEFT NEPHROLITHIASIS. INTRAOPERATIVELY, THE STONE BASKET COULD NOT BE DISLODGED FROM THE STONE AND ATTEMPTS WERE MADE TO REMOVE THE BASKET. THE BASKET WAS REMOVED AND IT WAS NOTED THAT BASKET FRAGMENT REMAINED IN THE LOWER POLE CALYX. THE PATIENT UNDERWENT A SECOND UROLOGICAL PROCEDURE ON AN UNKNOWN DATE TO REMOVE THE BASKET FRAGMENT. THE FRAGMENT WAS REMOVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063901050

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention