BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID? RX

    MDR report key: 3853983 · Received June 6, 2014

    Report

    Report Number
    3005099803-2014-02101
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE 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.

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE: MANUFACTURER REPORT #'S 3005099803-2014-02101 AND 3005099803-2014-02102. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LITHOTRIPTER COMPATABLE BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ATTEMPTING TO CAPTURE THE GALLSTONE FOR APPROXIMATELY 10 TO 15 MINUTES, THE BASKET FAILED TO CAPTURE THE STONE AND THE TIP OF THE BASKET DETACHED PREMATURELY INTO THE PATIENT'S DUODENUM. A SECOND LITHOTRIPTER WAS THEN INTRODUCED INTO THE PATIENT AND WHEN ATTEMPTING TO CAPTURE THE GALLSTONE, THE TIP OF THE BASKET DETACHED PREMATURELY INTO THE CYSTIC DUCT. THE PROCEDURE WAS COMPLETED BY USING A DIFFERENT DEVICE. 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 "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332005 TRAPEZOID? RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 16845908

    Patients

    Seq Age Sex Outcome Treatment
    1