BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD STONE BASKET

    MDR report key: 1250823 · Received November 26, 2008

    Report

    Report Number
    1018233-2008-00078
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 26, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ACTUAL SAMPLE WAS RETURNED AND EVALUATED IN A LABORATORY ENVIRONMENT. THE VISUAL INSPECTION VERIFIED THAT THE BASKET ASSEMBLY HAD DETACHED FROM BOTH DRIVE WIRES INSIDE OF THE SHEATH. THE ENDS OF THE BROKEN WIRES WERE EXAMINED UNDER 30X MAGNIFICATION AND SHOWED SIGNS OF NECKING DOWN BEFORE BREAKING WHICH IS INDICATIVE OF EXCESSIVE STRESS HAVING BEEN APPLIED DURING THE CAPTURING AND ATTEMPTED REMOVAL OF A LARGE STONE. A BASKET WIRE WAS ALSO OBSERVED TO HAVE BROKEN AND IT TOO SHOWED SIGNS OF NECKING DOWN PRIOR TO BREAKAGE. NONE OF THE BREAKS OCCURRED AT A MANUFACTURING POINT FURTHER SUPPORTING THE CONCLUSION THAT THE SAMPLE CONDITION WAS A RESULT OF POST-MANUFACTURING DAMAGE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NOTHING WAS FOUND THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES UNDER THE WARNINGS SECTION THAT 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 STONE BASKET IF THE OBJECT IS TOO LARGE TO BE REMOVED ENDOSCOPICALLY. UNDER THE CAUTION SECTION OF THE LABELING, IT STATES THAT OBJECTS THAT ARE TOO LARGE TO BE REMOVED THROUGH THE SHEATH OR THROUGH THE SCOPE CHANNEL WILL REQUIRE THE SCOPE AND BASKET TO BE REMOVED SIMULTANEOUSLY FROM THE URINARY TRACK. 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 PT INJURY. TAKE ACTION TO ALLEVIATE THE RESISTANCE. WHEN 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STONE REMOVAL PROCEDURE, THE STONE BASKET WAS TIGHTENED AROUND A STONE FRAGMENT AND THE DOCTOR WAS PULLING OUT THE SCOPE, BASKET AND FLEXIBLE SHEATH WHEN THE BASKET SNAPPED OFF AND REMAINED INSIDE THE PT. THE DOCTOR USED A RIGID CYSTOSCOPE WITH A 21 FRENCH SHEATH AND FLEXIBLE ALLIGATOR GRASPER TO REMOVE THE BASKET FROM THE PT DURING THE INITIAL PROCEDURE. THE INITIAL STONE WAS DESCRIBED AS A 1.1 CM COURSE STONE (BEFORE BROKEN WITH LASER) AND WAS LOCATED IN THE LOWER POLE OF THE LEFT KIDNEY. THE STONE HAD BEEN CAPTURED INSIDE THE BASKET AND A 270 MICRON HOLMIUM LASER FIBERWIRE HAD BEEN USED TO BREAK UP THE STONE INTO SMALLER PIECES PRIOR TO THE BASKET BREAKING. NO FURTHER COMPLICATIONS WERE REPORTED AND PT WAS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD STONE BASKET FFL C.R. BARD, INC. NA 03ISK021

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR URETEROSCOPE AND 14 FR. FLEXIBLE URETEROSCOPY| AND FLEXIBLE ALLIGATOR FORCEPS.| INITIALLY USED FLEX X-2| SHEATH, THEN