BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1181720 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04935
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 3005099803-2008-04941 AND -04940. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE BASKET FAILED TO OPEN AND BECAME STUCK IN THE CATHETER. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). A HYDRATOME RX SPHINCTEROTOME HAD BEEN ADVANCED THROUGH THE UNSPECIFIED TYPE OF SCOPE WHEN THE TIP CRACKED. A SECOND HYDRATOME RX SPHINCTEROTOME WAS ADVANCED BUT UNABLE TO BE USED TO PERFORM THE SPHINCTEROTOMY AS THE CUT WIRE WAS NOT BOWING OR BENDING. A 3RD HYDRATOME RX SPHINCTEROTOME WAS SUCCESSFULLY USED IN THE PROCEDURE. AN RX LITHOTRIPTER BASKET WAS THEN ADVANCED AND SUCCESSFULLY USED "MULTIPLE" TIMES BEFORE THE BASKET FAILED TO OPEN PROPERLY AND BECAME STUCK IN THE CATHETER. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER RX LITHOTRIPTER BASKET. THERE WERE NO PT COMPLICATIONS REPORTED; HOWEVER, THE PT'S CURRENT CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC M00510890 11356016

    Patients

    Seq Age Sex Outcome Treatment
    1