BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

    MDR report key: 1792098 · Received August 10, 2010

    Report

    Report Number
    3005099803-2010-03469
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    May 15, 2010
    Report Date
    July 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - WON'T OPEN. (B)(4). A VISUAL EVALUATION FOUND THAT THE DISTAL END OF THE CLEAR OUTER SHEATH/SIDECAR WAS PUSHED BACK FROM THE DISTAL END OF THE COIL FOR A LENGTH OF 1 MILLIMETER. ADDITIONALLY, THE SIDECAR HAD PEELED AT BOTH ENDS AND THE CLEAR OUTER SHEATH HAD BUCKLED ALONG THE WORKING LENGTH. THE COIL WAS FOUND TO BE STRETCHED (SEPARATED) AT THE DISTAL END OF THE BLACK HEATSHRINK. FUNCTIONALLY, WHEN THE HANDLE WAS ACTUATED, BOTH THE BASKET AND COIL ASSEMBLIES MOVED, WHICH KEPT THE BASKET FROM EXTENDING. THE PROXIMAL END OF THE CLEAR OUTER SHEATH WAS FOUND TO BE PULLED OUT FROM UNDERNEATH THE BLACK HEATSHRINK AND WAS 13.5 CENTIMETERS FROM THE HEATSHRINK. THE BASKET WIRES WERE FOUND TO BE DEFORMED WHEN THE BASKET WAS REMOVED FROM THE COIL ASSEMBLY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BASKET WOULD NOT EXTEND. DURING THE EVALUATION, THE COIL AND CLEAR OUTER SHEATH WERE FOUND TO BE SEPARATED FROM THE HEATSHRINK JOINT WHICH LIKELY OCCURRED DUE TO EXCESS FORCE APPLIED TO THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-02515 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKETS WERE USED DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS USED TO PARTIALLY CRUSH THE STONE. HOWEVER, THE PHYSICIAN WAS UNABLE TO OPEN THE BASKET TO MAKE ANOTHER ATTEMPT. A SECOND TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS THEN USED, BUT THE STONE WAS NOT ABLE TO BE CRUSHED AND THE TIP OF THE BASKET DETACHED INSIDE THE PATIENT. TWO OR THREE ATTEMPTS WERE MADE TO RETRIEVE THE TIP FROM THE PATIENT AND THE TIP WAS LEFT INSIDE THE PATIENT. THE STONE HAS NOT BEEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS FINISHED USING A FLEXIMA CATHETER TO DRAIN THE BILIARY TRACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SIDECAR PUSHBACK AND SHEATH TORN/SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR