BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 869115 · Received June 22, 2007

    Report

    Report Number
    6000123-2007-00028
    Event Type
    Malfunction
    Date Received
    June 22, 2007
    Date of Event
    February 1, 2007
    Report Date
    February 27, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAM OF THE RETURNED DEVICE REVEALED THAT APPROXIMATELY 10-15% OF THE PEBAX WAS DETACHED FROM THE CORE WIRE. SEVERAL LOCATIONS OF THE CORE WIRE WERE EXPOSED; THESE LOCATIONS SHOWED EVIDENCE OF COATING ADHESIVE. THE GUIDEWIRE ALSO HAD TWO KINKS APPROX 1.5 CM AND 4.0 CM FROM THE DISTAL END. THE PEBAX OUTER DIAMETER, IN UNDAMAGED SECTIONS, OF THE WIRE WAS CONFIRMED TO BE WITHIN SPEC. THE PHYSICAL EVIDENCE DISPLAYED BY THE DEVICE INDICATES THE DAMAGE WAS LIKELY CAUSED BY AN INTERACTION WITH ANOTHER DEVICE, IN CONJUNCTION WITH USER HANDLING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; ONE ADDITIONAL COMPLAINT FROM THE SAME FACILITY, WITH THE SAME FAILURE MODE WAS RECORDED FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; ONE ADDITIONAL COMPLAINT FROM THE SAME FACILITY, WITH THE SAME FAILURE MODE, WAS RECORDED FOR THIS LOT. THE MAY 2007 15-MONTH JAGWIRE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED AND NO DATA POINT EXCEEDED ANY COMPLAINT ALERT LIMIT. A CAPA FOR TIP SEPARATION ISSUES IS IN PROGRESS.

    Description of Event or Problem · 1

    NOTE: THIS MEDWATCH REPORT IS BEING SUBMITTED AS A RESULT OF RETURNED DEVICE EVAL. (SEE H10). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION 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 AN UNKNOWN DEVICE. PT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR EZB EZB BOSTON SCIENTIFIC M0055658011 8078181

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR