BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD FLATWIRE STONE BASKET

    MDR report key: 1082843 · Received July 24, 2008

    Report

    Report Number
    1018233-2008-00050
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 7, 2008
    Report Date
    July 24, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FFL
    PMA / PMN Number
    K961248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN, THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. SAMPLE WAS RECEIVED. THERE WERE 2 PIECES OF SHEATH RETURNED. RECEIVED BASKET HANDLE WITH THE DRIVE WIRE INSERTED INTO THE THUMB SLIDE. WITH THE THUMB SLIDE IN THE RETRACTED POSITION, THERE WAS APPROXIMATELY 24 INCHES OF SHEATH REMAINING FROM THE SHRINK TUBING. NO BASKET WAS RETURNED. ANOTHER PIECE OF SHEATH WAS RETURNED THAT MEASURED APPROXIMATELY 11 INCHES. UNDER 30X MAGNIFICATION, IT WAS NOTED THAT THE SEVERED PIECE OF SHEATH (11 INCH PIECE) HAD DRIED BLOOD ON BOTH ENDS. THE ENTIRE LENGTH OF THE TWO PIECES OF THE RETURNED SHEATH MEASURES APPROXIMATELY 25 INCHES OR 88.9 CENTIMETERS. THIS INDICATES THAT THE ENTIRE SHEATH SAMPLE WAS RETURNED AND BASED ON THE COLOR CODE OF THE BASKET HANDLE (PINK), IT CAN BE CONFIRMED THAT THE SAMPLE IS A FLATWIRE BASKET. THE DISTAL END OF THE DRIVEWIRE, THE BASKET AND THE DISTAL END OF THE INNER TEFLON TUBING IS MISSING. AT THE SEVERED POINT: THE SHEATH, INNER TEFLON TUBING, AND DRIVEWIRE APPEARED TO HAVE BEEN CUT AT AN ANGLE. THE INSTRUCTIONS FOR USE STATES: WARNINGS: SOME OBJECTS MAY BE TOO LARGE TO BE REMOVED ENDOSCOPICALLY USING A RETRIEVAL DEVICE. THE USE OF FLUOROSCOPY AND OR X-RAY TO DETERMINE THE SIZE OF THE OBJECT IS RECOMMENDED; DO NOT USE THE BASKET IF THE OBJECT IS TOO LARGE TO BE REMOVED ENDOSCOPICALLY. UNDER THE CAUTION SECTION: OBJECTS THAT ARE TOO LARGE TO BE RECOVERED THROUGH THE SHEATH OR THROUGH THE SCOPE CHANNEL WILL REQUIRE THE SCOPE AND BASKET TO BE REMOVED SIMULTANEOUSLY FROM THE URINARY TRACT. IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE, STOP AND DETERMINE THE SOURCE OF THE RESISTANCE, AS CONTINUED RESISTANCE MAY DAMAGE THE DEVICE AND COULD RESULT IN PATIENT INJURY. TAKE ACTION TO ALLEVIATE THE RESISTANCE. WHERE NECESSARY, USE OF A LITHOTRITE MAY BE REQUIRED TO REDUCE THE STONE BURDEN WITHIN THE BASKET, PROVIDED THAT NO DIRECT CONTACT IS MADE WITH THE STONE BASKET. PRECAUTIONS: DO NOT ALLOW THE DEVICE TO COME IN CONTACT WITH ANY ELECTRIFIED INSTRUMENT. POTENTIAL COMPLICATIONS THAT MAY RESULT FROM THE USE OF A BASKET IN AN ENDOSCOPIC UROLOGICAL PROCEDURE INCLUDE BUT ARE NOT LIMITED TO: PERFORATION, EDEMA, EVULSION, ENTRAPMENT, BASKET INVERSION, HEMORRHAGE, INABILITY TO DISENGAGE FROM IRRETRIEVABLE OBJECT. BASELINE REPORT PREVIOUSLY FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STONE REMOVAL PROCEDURE IN 2008, THE BASKET BROKE AND A PORTION OF THE WIRE WAS LEFT IN THE PATIENT'S URETER. THE PATIENT HAD MULTIPLE STONE FRAGMENTS. THE SIZE OF THE STONES IS UNKNOWN. THE PATIENT WAS TREATED BY ANOTHER PHYSICIAN AND THE BASKET WAS REMOVED THE FOLLOWING DAY. ACCORDING TO THE DOCTOR, THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLATWIRE STONE BASKET FFL C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention