BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1172495 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04723
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, THE BASKET FAILED TO CRUSH THE STONE. THE LESION WAS LOCATED IN THE COMMON BILE DUCT (CBD). UPON OPENING THE PACKAGE OF THE RX LITHOTRIPTER COMPATABLE BASKET, IT WAS NOTED THAT THE BASKET WAS PARTIALLY OPEN. THE BASKET WAS LOADED ONTO AN UNSPECIFIED GUIDE WIRE AND ADVANCED TO THE CBD. THE PHYSICIAN WAS ABLE TO CAPTURE THE STONE WITHIN THE BASKET, HOWEVER, THE BASKET WAS UNABLE TO CRUSH THE STONE. SEVERAL MORE ATTEMPTS WERE MADE TO CRUSH THE STONE WITHOUT SUCCESS. THE PHYSICIAN RELEASED THE STONE FROM THE BASKET AND REMOVED THE DEVICE. UPON INSPECTION, IT WAS NOTED THAT THE BASKET WAS UNABLE TO PROPERLY CLOSE. ANOTHER MANUFACTURER'S BASKET WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC M00510890 11661444

    Patients

    Seq Age Sex Outcome Treatment
    1