BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1954701 · Received January 10, 2011

    Report

    Report Number
    3005099803-2011-00068
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAG PRECURSOR GUIDEWIRE WAS USED DURING A SPHINCTEROTOMY/STONE REMOVAL PROCEDURE ON (B)(6), 2010.ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE WHEN THE GUIDEWIRE WAS NAVIGATED INTO THE COMMON BILE DUCT, THE HYDROPHILIC TIP OF THE DEVICE DETACHED AND FELL INTO THE PATIENT OUTSIDE OF THE COMMON BILE DUCT. THE PHYSICIAN LEFT THE PIECE IN TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M0055658011 12625589

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR