BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 3223538 · Received July 12, 2013

    Report

    Report Number
    3005099803-2013-06148
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN BUT WAS REPORTED TO BE OVER 65 YEARS OLD. THE PATIENT'S EXACT WEIGHT IS UNKNOWN BUT WAS REPORTED TO BE OVER 80 KG. (B)(6). REPORTED EVENT OF DISTAL HYDROPHILIC TIP DETACHED. REPORTED EVENT OF GUIDEWIRE DIFFICULTY WITHDRAWING. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE GUIDEWIRE WAS ADVANCED OUT OF THE CATHETER WHEN THE TIP OF THE GUIDEWIRE LOOPED BEFORE ENTERING THE STENOSIS. THE PHYSICIAN ATTEMPTED TO PULL THE WIRE BACK INTO THE CATHETER BUT IT WAS REPORTED THAT THE GUIDEWIRE WAS CAUGHT. THE HYDROPHILIC TIP WAS PURPOSELY STRIPPED OFF. THE HYDROPHILIC TIP DETACHED INSIDE THE BILE DUCT, EXPOSING THE TIP OF THE METAL COREWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321942 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0055660010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other