BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC BILIARY CATHETER

    MDR report key: 2113306 · Received June 3, 2011

    Report

    Report Number
    3005099803-2011-01896
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQR
    PMA / PMN Number
    K946358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED; 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ELECTRIC CURRENT TO THE DEVICE COULD NOT BE APPLIED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC BILIARY CATHETER DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535210 13805069

    Patients

    Seq Age Sex Outcome Treatment
    1