BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE¿

    MDR report key: 2822893 · Received November 7, 2012

    Report

    Report Number
    3005099803-2012-05079
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF TIP DETACHED INSIDE OF PATIENT. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE GUIDEWIRE HAD DETACHED EXPOSING THE COREWIRE. THE PRESENCE OF ADHESIVE REMNANTS WAS FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO COREWIRE. NO EVIDENCE OF COREWIRE FRACTURE WAS NOTED. NO DAMAGE WAS NOTED TO THE COREWIRE OR PTFE COATING. THE OUTER DIAMETER OF THE GUIDEWIRE WAS FOUND TO BE WITHIN SPECIFICATION. IT IS POSSIBLE THAT THE INTERACTION WITH OTHER DEVICES AND HANDLING OF THE DEVICE MAY HAVE CONTRIBUTED TO THE FAILURES. 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2012-05079 ADDRESSES THE FIRST JAGWIRE GUIDEWIRE, MANUFACTURER REPORT #3005099803-2012-05080 ADDRESSES THE SECOND JAGWIRE GUIDEWIRE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT TWO JAGWIRE GUIDEWIRES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE FIRST WIRE WAS PLACED IN THE DUODENAL PAPILLA, THE TIP DETACHED INSIDE OF THE PATIENT EXPOSING THE TIP OF THE COREWIRE. THE GUIDEWIRE WAS REMOVED FROM THE PATIENT AND A SECOND JAGWIRE GUIDEWIRE WAS OPENED. HOWEVER, THE SAME PROBLEM OCCURRED. NEITHER DETACHED COMPONENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION WAS REPORTED AS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2012-05079 ADDRESSES THE FIRST JAGWIRE GUIDEWIRE, MANUFACTURER REPORT #3005099803-2012-05080 ADDRESSES THE SECOND JAGWIRE GUIDEWIRE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT TWO JAGWIRE GUIDEWIRES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE FIRST WIRE WAS PLACED IN THE DUODENAL PAPILLA, THE TIP DETACHED INSIDE OF THE PATIENT EXPOSING THE TIP OF THE COREWIRE. THE GUIDEWIRE WAS REMOVED FROM THE PATIENT AND A SECOND JAGWIRE GUIDEWIRE WAS OPENED. HOWEVER, THE SAME PROBLEM OCCURRED. NEITHER DETACHED COMPONENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION WAS REPORTED AS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2012-05079 ADDRESSES THE FIRST JAGWIRE GUIDEWIRE, MANUFACTURER REPORT #3005099803-2012-05080 ADDRESSES THE SECOND JAGWIRE GUIDEWIRE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT TWO JAGWIRE GUIDEWIRES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE FIRST WIRE WAS PLACED IN THE DUODENAL PAPILLA, THE TIP DETACHED INSIDE OF THE PATIENT EXPOSING THE TIP OF THE COREWIRE. THE GUIDEWIRE WAS REMOVED FROM THE PATIENT AND A SECOND JAGWIRE GUIDEWIRE WAS OPENED. HOWEVER, THE SAME PROBLEM OCCURRED. NEITHER DETACHED COMPONENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION WAS REPORTED AS STABLE POST PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR