BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE¿

    MDR report key: 2231843 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02974
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED NO ANOMALIES WITH THE GUIDEWIRE. NO PART OF THE GUIDEWIRE HAD DETACHED AND NO DAMAGE WAS NOTED. THE CIRCUMSTANCES UNDER WHICH THE COSTUMER STATES THAT A FRAGMENT FROM THE DISTAL TIP DETACHED FROM THE DEVICE AND THAT IT FELL OF INTO THE PATIENT CANNOT BE DETERMINED SINCE THE UNIT RETURNED PRESENTS THE DISTAL TIP INTACT. THEREFORE, THE MOST PROBABLE ROOT CAUSE WILL BE DOCUMENTED AS "NOT CONFIRMED". A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. SIMILAR COMPLAINT TREND REVIEW REVEALED NO OTHER COMPLAINTS REPORTED FOR LOT NUMBER 14164571.

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    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 COMPLAINANT, DURING THE PROCEDURE THE TIP OF THE GUIDEWIRE DETACHED FOLLOWING SEVERAL CANNULATION ATTEMPTS. THE PHYSICIAN LOCATED THE DETACHED PIECE WITH A FLOUROSCOPE, BUT WAS UNABLE TO RETRIEVE IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN "STABILIZED." UPDATE (B)(6) 2011 INVESTIGATION RESULTS HAVE REVEALED NO ANOMALIES WITH THE GUIDEWIRE, MAKING THIS EVENT NON-REPORTABLE. IT WAS CONFIRMED WITH THE SITE THAT THE CORRECT GUIDEWIRE WAS RETURNED.

    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 COMPLAINANT, DURING THE PROCEDURE THE TIP OF THE GUIDEWIRE DETACHED FOLLOWING SEVERAL CANNULATION ATTEMPTS. THE PHYSICIAN LOCATED THE DETACHED PIECE WITH A FLUOROSCOPE, BUT WAS UNABLE TO RETRIEVE IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M0055658011 14164571

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR