BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID? RX

    MDR report key: 3872875 · Received June 13, 2014

    Report

    Report Number
    3005099803-2014-02240
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) TIP DID NOT DETACH. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE LOT NUMBER WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE REPORTED COMPLAINT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATABLE BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CRUSH AN 11MM STONE BUT FAILED. THE PHYSICIAN ATTEMPTED TO DETACH THE BASKET TIP BUT WAS ALSO UNSUCCESSFUL. THE DEVICE HANDLE WAS CUT OFF WITH WIRE CUTTERS AND ITS WIRES WERE ATTACHED TO AN EMERGENCY LITHOTRIPTER HANDLE. AN ATTEMPT TO CRUSH THE STONE WAS MADE, HOWEVER, THIS STILL DID NOT CRUSH THE STONE. THE NURSE STUCK HER FINGER ON THE PULL WIRE OF THE DEVICE, WHILE UNRAVELING THE DEVICE FROM THE EMERGENCY HANDLE. THERE WAS NO MEDICAL INTERVENTION REPORTED TO TREAT THE WIRE STICK. A 10MM BALLOON (MANUFACTURER UNKNOWN) WAS USED TO DILATE THE COMMON BILE DUCT AND REMOVE THE BASKET WITH CAPTURED STONE TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349984 TRAPEZOID? RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890 16695767

    Patients

    Seq Age Sex Outcome Treatment
    1