BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE¿

    MDR report key: 3013494 · Received March 20, 2013

    Report

    Report Number
    3005099803-2013-01578
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF TIP DETACHMENT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION YET; 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 COMMON BILE DUCT STONE REMOVAL PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE TIP OF THE GUIDEWIRE DETACHED INTO THE PATIENT. THE TIP OF THE COREWIRE WAS EXPOSED. THE DETACHED FRAGMENT WAS ATTEMPTED TO BE RECOVERED WITH FORCEPS, BUT FELL INTO THE PATIENT'S DUODENUM. THE PHYSICIAN DID NOT EXPRESS ANY CONCERNS REGARDING THE UNRETRIEVED FRAGMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT INJURIES REPORTED. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116540 JAGWIRE¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0055658011 0015306646

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other