BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 867031 · Received June 20, 2007

    Report

    Report Number
    6000123-2007-00024
    Event Type
    Malfunction
    Date Received
    June 20, 2007
    Date of Event
    November 28, 2006
    Report Date
    February 27, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. VISUAL INSPECTION REVEALED APPROX 1.5CM OF A DISTAL SECTION OF THE PEBAX WAS TORN FROM THE WIRE. A 2CM (APPROXIMATE) SECTION OF THE ORIGINAL PEBAX, REMAINING ON THE WIRE, WAS CUT AND TORN; ALTHOUGH THE COREWIRE WAS EXPOSED, IT WAS NOT FRACTURED. THE OUTER DIAMETER OF THE UNDAMAGED PEBAX SECTION WAS CONFIRMED TO BE WITHIN MFG SPECIFICATION AT SEVERAL LOCATIONS ALONG IT'S LENGTH. DURING THE MFG PROCESS, A 100% INSPECTION OF THE ENTIRE LENGTH OF THE PEBAX TIP IS PERFORMED TO VERIFY IT'S INTEGRITY. THE INSPECTION INCLUDES CHECKING TIP COVERAGE, COATING SMOOTHNESS AND COATING UNIFORMITY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORP IN 2007, THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ON A FEMALE PT, THE PHYSICIAN ATTEMPTED TO "DELIVER THE GUIDEWIRE THROUGH THE SPHINCTEROTOME (WHEN) THE WIRE'S TIP COVER FELL APART SHOWING THE METAL INSIDE". THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. PT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR EZB BOSTON SCIENTIFIC M0055658011 7356743

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR