BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSAGE BILIARY DILATION CATHETER

    MDR report key: 612347 · Received May 27, 2005

    Report

    Report Number
    6000048-2005-00072
    Event Type
    Malfunction
    Date Received
    May 27, 2005
    Date of Event
    April 11, 2005
    Report Date
    April 11, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    GCC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE PHYSICIAN WAS PERFORMING A THERAPEUTIC DILATION OF A PT'S (AGE AND GENDER UNK) BILIARY DUCT, BUT THE DURING THE PROCEDURE THE DISTAL PORTION OF THE DILATION PLUG BROKE OFF IN THE PT'S BILIARY DUCT. IT WAS INDICATED THAT THE DETACHED SECTION OF THE DEVICE WAS SUCCESSFULLY REMOVED BY THE DOCTOR WITH THE AID OF A BASKET DEVICE. THE PROCEDURE WAS THEN HALTED AND RESCHEDULED FOR ANOTHER DATE. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE AFFECT TO THE PT AS A RESULT OF THE REPORTED MALFUNCTION AND THAT THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSAGE BILIARY DILATION CATHETER DILATATION CATHETER GCC BOSTON SCIENTIFIC CORP. NA 49033320

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other