BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORPORATION

    MDR report key: 1474399 · Received September 13, 2009

    Report

    Report Number
    MW5012696
    Event Type
    Injury
    Date Received
    September 13, 2009
    Date of Event
    August 3, 2009
    Report Date
    September 13, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ELECTIVELY TAKEN TO THE OPERATING ROOM IN 2009, FOR CYSTOSCOPY, POSSIBLE RIGHT URETEROSCOPY/RIGHT STENT PLACEMENT AND STONE BASKETING. DURING THE PROCEDURE, THE STONE WAS TOO BIG TO BE EXTRACTED VIA THE NITINOL RETRIEVAL STONE BASKET AND A URETERAL STENT WAS PLACED. PATIENT WAS DISCHARGED HOME LATER THAT DAY WITH A SCHEDULED UROLOGY PROCEDURE FOR THE FOLLOWING MONTH, FOR LASER LITHOTRIPSY FOR RIGHT URETER STONE REMOVAL. THE PATIENT RETURNED ON THE SAME DAY, FOR HIS SCHEDULED OR PROCEDURE: RIGHT URETEROSCOPY WITH LASER LITHOTRIPSY AND RIGHT STENT PLACEMENT. DURING THE PROCEDURE, AT MIDURETER, USING THE URETEROSCOPE, THE STONE WAS IDENTIFIED AND ALSO A DISTAL FRAGMENT OF THE NITINOL RETRIEVAL BASKET FROM THE PREVIOUS SURGERY IN 2009. BOTH THE STONE AND NITINOL RETRIEVAL BASKET WERE REMOVED AND SENT TO PATHOLOGY FOR PROCESSING. PATIENT WAS DISCHARGED TO HOME LATER THAT DAY. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: KIDNEY STONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other