BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX LITHOTRIPTER

    MDR report key: 795306 · Received December 14, 2006

    Report

    Report Number
    6000048-2006-00633
    Event Type
    Injury
    Date Received
    December 14, 2006
    Date of Event
    November 22, 2006
    Report Date
    November 24, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RECEIVED BY THIS MFR. AN EVALUATION HAS NOT BEEN PERFORMED, THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (PT'S GENDER UNK), USING A TRAPEZOID RX LITHOTRIPTER, THE TIP OF THE BASKET DETACHED FROM THE DEVICE. THE DETACHMENT OCCURRED DURING AN ATTEMPT TO CLOSE THE BASKET AROUND A SECOND STONE THAT WAS BEING REMOVED FROM THE COMMON BILE DUCT. THE PHYSICIAN REMOVED THE STONE USING A STONE EXTRACTOR BALLOON. THE PT'S CONDITION WAS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER LQC LQC BOSTON SCIENTIFIC M00510880 8629557

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention