BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE¿

    MDR report key: 2191046 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02668
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    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. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL TIP SECTION HAD DETACHED, EXPOSING THE TIP OF THE COREWIRE. NO COREWIRE FRACTURE EVIDENCE WAS FOUND AND THERE WAS NO DAMAGE NOTED TO THE PTFE JACKET. THE DISTAL TIP APPEARS TO HAVE BEEN PULLED OR PUSHED AGAINST RESISTANCE. IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE DISTAL TIP SECTION DAMAGE, INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION. THEREFORE, "OPERATIONAL CONTEXT" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE TIP OF THE JAGWIRE DETACHED INSIDE OF THE PATIENT AFTER SEVERAL CANNULATIONS. THE PHYSICIAN ATTEMPTED TO RECOVER THE DETACHED PIECE, BUT WAS UNABLE TO DO SO. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN REPORTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE TIP OF THE JAGWIRE DETACHED INSIDE OF THE PATIENT AFTER SEVERAL CANNULATIONS. THE PHYSICIAN ATTEMPTED TO RECOVER THE DETACHED PIECE, BUT WAS UNABLE TO DO SO. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN REPORTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention