BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 2821046 · Received November 6, 2012

    Report

    Report Number
    3005099803-2012-05195
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    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

    (B)(4):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

    CORRECTION: THE DEVICE WAS RECEIVED ON (B)(4) 2012,HOWEVER AN EVALUATION HAD NOT YET BEEN PERFORMED. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE PEBAX SECTION HAD DETACHED FROM THE GUIDEWIRE, EXPOSING THE COREWIRE TIP. THE PRESENCE OF ADHESIVE REMNANTS INDICATE THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. THERE WAS NO EVIDENCE OF A COREWIRE FRACTURE OR DAMAGE TO THE PTFE JACKET. IT IS POSSIBLE THAT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED AND MAY HAVE CONTRIBUTED TO THE FAILURE. NO PATIENT COMPLICATIONS WERE REPORTED. THEREFORE, "OPERATIONAL CONTEXT" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2012 THAT A JAGWIRE GUIDEWIRE WAS USED IN A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE TOOK PLACE ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, THE TIP OF THE GUIDEWIRE BROKE OFF INSIDE OF THE PATIENT DURING THE PROCEDURE. THE FRAGMENT CAUSED INFLAMMATION IN THE PATIENT'S PANCREAS AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO ATTEMPT TO REMOVE THE DETACHED PIECE. HOWEVER, THE PROCEDURE WAS UNSUCCESSFUL AND THE PIECE REMAINED INSIDE THE PATIENT. THE PATIENT SUFFERED FROM INFLAMMATION AND REQUIRED ADDITIONAL MEDICAL INTERVENTION TO ATTEMPT TO REMOVE THE DETACHED FRAGMENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE NOT GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A JAGWIRE GUIDEWIRE WAS USED IN A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE TOOK PLACE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE TIP OF THE GUIDEWIRE BROKE OFF INSIDE OF THE PATIENT DURING THE PROCEDURE. THE FRAGMENT CAUSED INFLAMMATION IN THE PATIENT'S PANCREAS AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO ATTEMPT TO REMOVE THE DETACHED PIECE. HOWEVER, THE PROCEDURE WAS UNSUCCESSFUL AND THE PIECE REMAINED INSIDE THE PATIENT. THE PATIENT SUFFERED FROM INFLAMMATION AND REQUIRED ADDITIONAL MEDICAL INTERVENTION TO ATTEMPT TO REMOVE THE DETACHED FRAGMENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE NOT GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0055658010 14864507

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R