BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1801850 · Received August 16, 2010

    Report

    Report Number
    3005099803-2010-03518
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 26, 2010
    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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) (FAILED TO DETACH). (B)(4):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. BSC REFERENCE: A00236577 / 1649834

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STONE WAS SUCCESSFULLY CAPTURED WITHIN THE BASKET, BUT WAS UNABLE TO BE REMOVED DUE TO ITS LARGE SIZE. THE HANDLE OF THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS INSERTED INTO AN ALLIANCE II HANDLE TO PROVIDE ADDITIONAL FORCE TO CRUSH THE STONE. HOWEVER, DURING THE ATTEMPTED LITHOTRIPSY, THE HANDLE THUMB RING CRACKED PRIOR TO DETACHMENT OF THE BASKET TIP WHICH PREVENTED THE BASKET FROM BEING CLOSED ANY FURTHER. THE HANDLE WAS THEN CUT TO ALLOW FOR REMOVAL OF THE BASKET USING A SOEHENDRA EMERGENCY HANDLE, BUT THE DEVICE WAS UNABLE TO BE LOCATED. HOWEVER, THE ACCOUNT WAS ABLE TO MANIPULATE THE SCOPE IN A MANNER THAT ALLOWED THE STONE AND BASKET TO BE REMOVED FROM THE CBD TO 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 GOOD.

    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 M00510880

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR