BEUDAMED
    FDA Adverse Event Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 843865 · Received April 27, 2007

    Report

    Report Number
    6000043-2007-00049
    Date Received
    April 27, 2007
    Report Date
    April 6, 2007
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT CONFIRMED. THE SHEATH AND DRIVE WIRE OF THE DEVICE ARE SEPARATED 14.5 MM FROM THE HANDLE. ONE OF THE 4 BASKET WIRES IS MISSING A 7MM LONG PIECE FROM NEAR THE KNOT. MICROSCOPIC EXAMINATION OF THE ENDS OF THE WIRES SHOW THEY ARE ROUGH AND JAGGED. WIRES THAT ARE INTENTIONALLY CUT HAVE EVEN ENDS AND WIRES THAT HAVE BEEN CUT WITH A LASER SHOW ROUNDED ENDS WITH SOME MELTED APPEARANCE. THE MECHANISM TO PRODUCE THE JAGGED ENDS SEEN ON THE DEVICE IS NOT KNOWN. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FROM THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES THAT COULD BE ASSOCIATED WITH THIS INCIDENT. THE ROOT CAUSE FOR THE BROKEN WIRE ON THE BASKET IS UNK. A MARCH 2007 FIFTEEN (15) - MONTH ZERO TIP BASKET COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE DISTAL END OF THE DEVICE WORKING LENGTH WAS FOUND TO BE DETACHED FROM THE DEVICE HANDLE APPROXIMATELY 145MM FROM THE DISTAL END OF THE HANDLE. THE ENDS OF THE OUTER SHEATH AND DRIVE WIRE WHERE THE COMPONENTS WERE DETACHED WERE CUT CLEAN. THE CLEANNESS OF THE CUT INDICATES THE DEVICE MAY HAVE BEEN INTENTIONALLY CUT WITH A SHARP OBJECT PRIOR TO BEING RETURNED. THE DEVICE BASKET WAS PRESENT ON THE DISTAL END OF THE DETACHED SECTION OF THE DRIVE WIRE. ONE OF THE FOUR BASKET WIRES HAD A FRAGMENT APPROXIMATELY 7MM LONG MISSING FROM THE MIDDLE OF THE BASKET WIRE. THE ENDS OF THE BROKEN LEG OF THE DEVICE BASKET WERE EXAMINED UNDER MAGNIFICATION. THE ENDS OF THE BROKEN WIRE EXHIBITED DAMAGE CONSISTENT WITH THAT CAUSED WHEN FIRED ON BY A LITHOTRITE (LASER). ONE OF THE ADJACENT LEGS OF THE BASKET ALSO EXHIBITED DAMAGE CONSISTENT WITH THAT CAUSED WHEN FIRED ON BY A LITHOTRITE (LASER) IN THE SAME BASIC LOCATION FROM THE DISTAL END AS THE BROKEN LEG. BASED ON FURTHER ANALYSIS OF THE RETURNED DEVICE, IT HAS BEEN DETERMINED THAT THE BASKET LEG WAS MOST LIKELY BROKEN DUE TO THE BASKET BEING CONTACTED BY A LITHOTRITE (LASER). IT IS NOT POSSIBLE TO DETERMINE IF USE OF THE LASER WAS NECESSARY. THEREFORE, SINCE THE DEFECT WAS IDENTIFIED DURING THE PROCEDURE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A THERAPEUTIC STONE RETRIEVAL PROCEDURE OCCURRED IN 2007. DURING THE PROCEDURE, ONE OF THE WIRES OF THE BASKET OF OUR STONE RETRIEVAL DEVICE DETACHED IN THE PT'S URETER. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN WIRE THROUGH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP RETRIEVAL BASKET SUCCESSFULLY. NO PT COMPLICATION SUSTAINED AS A RESULT OF THE WIRE BREAK AND DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A THERAPEUTIC STONE RETRIEVAL PROCEDURE OCCURRED ON (B)(6), 2007. DURING THE PROCEDURE ONE OF THE WIRES OF THE BASKET OF OUR STONE RETRIEVAL DEVICE DETACHED IN THE PATIENT'S RIGHT URETER. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN WIRE THROUGH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP RETRIEVAL BASKET SUCCESSFULLY. NO PATIENT COMPLICATION SUSTAINED AS A RESULT OF THE WIRE BREAK AND DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL M0063901030

    Patients

    Seq Age Sex Outcome Treatment
    1