BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE¿

    MDR report key: 3082167 · Received April 29, 2013

    Report

    Report Number
    3005099803-2013-03096
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 11, 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 Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. REPORTED EVENT OF TIP DETACHMENT. 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 UPON REMOVING THE CANNULATION JAGWIRE FROM THE COMMON BILE DUCT AND SCOPE, THE TIP OF THE JAGWIRE DETACHED. A FLUOROSCOPY CONFIRMED THAT THE TIP OF THE JAGWIRE REMAINED IN THE PATIENT'S COMMON BILE DUCT. THE SITE HAS STATED THAT A RETRIEVAL ATTEMPT WAS MADE IN APRIL (WITH NO SPECIFIC DATE) THE PHYSICIAN DIDN'T FIND ANYTHING LEFT IN THE DUCT AND STATED "THE DETACHED TIP OF THE JAGWIRE MIGRATED OUT OF THE DUCT AND EVERYTHING WAS FINE." THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184096 JAGWIRE¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556841

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention