BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 4973729 · Received August 5, 2015

    Report

    Report Number
    3005099803-2015-02268
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    OCY
    PMA / PMN Number
    K141820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED GUIDEWIRE REVEALED THAT THE DISTAL TIP WAS PARTIALLY DETACHED AND THE COREWIRE TIP WAS EXPOSED. PRESENCE OF ADHESIVE REMNANTS WERE FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. NO EVIDENCE OF COREWIRE FRACTURE WAS FOUND. THE COMPLAINT IS CONSISTENT WITH THE RETURNED GUIDEWIRE SINCE THE DISTAL TIP WAS DETACHED, AND THE COREWIRE TIP WAS EXPOSED. IT IS MOST PROBABLE THAT ANATOMICAL OR PROCEDURAL FACTORS COULD HAVE GENERATED THE FAILURE ENCOUNTERED. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT.¿ A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER 18 YEARS OLD. (B)(4) GUIDEWIRE DISTAL TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2015-02264, 3005099803-2015-02265, 3005099803-2015-02266, 3005099803-2015-02267, 3005099803-2015-02268, AND 3005099803-2015-02269 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. FIVE MORE JAGWIRE GUIDEWIRES WERE USED AND DURING THE PROCEDURE, THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. NO PART OF THE GUIDEWIRE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2015-02264, 3005099803-2015-02265, 3005099803-2015-02266, 3005099803-2015-02267, 3005099803-2015-02268, AND 3005099803-2015-02269 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. FIVE MORE JAGWIRE GUIDEWIRES WERE USED AND DURING THE PROCEDURE, THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. NO PART OF THE GUIDEWIRE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512666 JAGWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0055658010 16404271

    Patients

    Seq Age Sex Outcome Treatment
    1