BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 1252104 · Received December 4, 2008

    Report

    Report Number
    3005099803-2008-06938
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 3005099803-2008-06909. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, RESISTANCE WAS ENCOUNTERED AND A COATING DETACHMENT OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE DUODENUM. ANOTHER MFR'S DUODENOSCOPE WAS ADVANCED TO THE PAPILLA IN THE DUODENUM. THE ULTRATOME XL SPHINCTEROTOME WAS ADVANCED AND AN ATTEMPT WAS MADE TO CANNULATE THE PAPILLA, HOWEVER, THE SPHINCTEROTOME WAS UNABLE TO BE ADVANCED TO THE COMMON BILE DUCT (CBD). IOMERON 250 CONTRAST WAS INJECTED NEAR THE ENTRANCE OF CBD AND THE ZEBRA GUIDE WIRE WAS INSERTED THROUGH THE GUIDE WIRE LUMEN OF THE ULTRATOME XL SPHINCTEROTOME. "SLIGHT" RESISTANCE WAS ENCOUNTERED UPON ADVANCING THE ZEBRA GUIDE WIRE ACROSS THE PAPILLA AND, FOLLOWING THREE ATTEMPTS, THE GUIDE WIRE WAS UNABLE TO BE ADVANCED TO THE CBD. THE GUIDE WIRE WAS REMOVED INTACT AND ANOTHER MFR'S 0.035 GUIDE WIRE WAS ADVANCED THROUGH THE WIRE LUMEN OF THE SPHINCTEROTOME, HOWEVER, SLIGHT RESISTANCE WAS AGAIN ENCOUNTERED AND, FOLLOWING THREE ATTEMPTS, THE GUIDE WIRE WAS UNABLE TO BE ADVANCED TO THE CBD. THE GUIDE WIRE WAS REMOVED INTACT AND, WITHOUT THE USE OF THE ELEVATOR, THE 0.035 JAG PRECURSOR GUIDE WIRE WAS ADVANCED THROUGH THE WIRE LUMEN OF THE SPHINCTEROTOME. SLIGHT RESISTANCE WAS ENCOUNTERED UPON ATTEMPTING TO CANNULATE THE PAPILLA AND WITHIN ONE MINUTE AND TWO ATTEMPTS TO ADVANCE TO THE GUIDE WIRE TO THE CBD, THE PHYSICIAN NOTED THAT APPROXIMATELY 0.6CM OF THE DISTAL END OF THE JAGWIRE'S HYDROPHILIC COATING HAD DETACHED AND REMAINED IN THE DUODENUM. THE PHYSICIAN REMOVED THE JAGWIRE AND SPHINCTEROTOME IN TANDEM AND ABORTED THE PROCEDURE WITH NO ATTEMPT TO RETRIEVE THE DETACHED PORTION OF THE GUIDE WIRE. THE PT'S STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC M0055658011 9246133

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention LIVER ABSCESS| COOK METRO 0.035/480 GUIDE WIRE| OLYMPUS NON-V DUOENOSCOPE