BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 1408886 · Received February 20, 2009

    Report

    Report Number
    3005099803-2009-00693
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    December 8, 2008
    Report Date
    January 23, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR. REPORT # 3005099803-2009-00030. UPON RETURN OF THE FLEXIMA BILIARY STENT DELIVERY SYSTEM, THE GUIDE WIRE WAS INCLUDED AND IT WAS NOTED THE OUTER COATING HAD PEELED IN MULTIPLE PLACES. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE GUIDE WIRE DURING THE PROCEDURE. IT WAS REPORTED THAT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS BEING PERFORMED TO TREAT A LESION IN AN UNSPECIFIED "BILIARY PASSAGE". THE 0.035 JAG PRECURSOR GUIDE WIRE WAS PLACED AND THE 8.5FR/5CM BILIARY STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. UPON ATTEMPTING TO DEPLOY THE STENT, DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED AND THE RO MARKERBAND ON THE SDS DETACHED AND REMAINED INSIDE THE PATIENT'S INTESTINE. THE STENT WAS ABLE TO BE DEPLOYED, HOWEVER, THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE DETACHED PORTION AND NOTED THAT IT SHOULD PASS ON ITS OWN. THE PATIENT'S STATUS WAS REPORTED AS "FINE". UPON FOLLOW-UP WITH THE PHYSICIAN IT WAS THOUGHT THAT THE RO MARKERBAND WOULD NOT PASS ON ITS OWN. ANOTHER INTERVENTION WAS PERFORMED A WEEK AFTER THE INITIAL PROCEDURE AT WHICH TIME AN UNSPECIFIED RETRIEVAL BASKET WAS USED TO REMOVE THE "RESIDUE". THE PATIENT'S STATUS WAS REPORTED AS "GOOD" FOLLOWING THE SECOND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM - GUIDEWIRE MDM BOSTON SCIENTIFIC M0055658011 12135305

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR