BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE?

    MDR report key: 3980518 · Received August 5, 2014

    Report

    Report Number
    3005099803-2014-02671
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    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

    A VISUAL EXAMINATION OF THE GUIDEWIRE REVEALED THAT THE DISTAL TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. PRESENCE OF ADHESIVE REMNANTS WERE FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. NO EVIDENCE OF COREWIRE FRACTURED. THE COMPLAINT IS CONSISTENT WITH THE RETURN THAT THE DISTAL TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE IS "HANDLING DAMAGE." SINCE THE MANUFACTURING OF THIS COMPLAINT DEVICE, A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF GUIDEWIRE TIP DETACHED EXPOSING THE COREWIRE TIP. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWELVE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2014-02671, 3005099803-2014-02672, 3005099803-2014-02673, 3005099803-2014-02674, 3005099803-2014-02675, 3005099803-2014-02676, 3005099803-2014-02677, 3005099803-2014-02678, 3005099803-2014-02679, 3005099803-2014-02680, 3005099803-2014-02681 AND 3005099803-2014-02682 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) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP OF THE JAGWIRE GUIDEWIRE DETACHED INSIDE THE PATIENT EXPOSING THE TIP OF THE METAL COREWIRE. A SECOND JAGWIRE GUIDEWIRE WAS USED, HOWEVER, THE HYDROPHILIC TIP ALSO DETACHED INSIDE THE PATIENT EXPOSING THE TIP OF THE METAL COREWIRE. THE DETACHED TIPS WERE SUCCESSFULLY RETRIEVED USING A BALLOON. TEN MORE JAGWIRE GUIDEWIRES WERE OPENED AND DURING PREPARATION, THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE PROCEDURE WAS COMPLETED USING THE THIRTEENTH JAGWIRE GUIDEWIRE. 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 TWELVE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2014-02671, 3005099803-2014-02672, 3005099803-2014-02673, 3005099803-2014-02674, 3005099803-2014-02675, 3005099803-2014-02676, 3005099803-2014-02677, 3005099803-2014-02678, 3005099803-2014-02679, 3005099803-2014-02680, 3005099803-2014-02681 AND 3005099803-2014-02682 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) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP OF THE JAGWIRE GUIDEWIRE DETACHED INSIDE THE PATIENT EXPOSING THE TIP OF THE METAL COREWIRE. A SECOND JAGWIRE GUIDEWIRE WAS USED, HOWEVER, THE HYDROPHILIC TIP ALSO DETACHED INSIDE THE PATIENT EXPOSING THE TIP OF THE METAL COREWIRE. THE DETACHED TIPS WERE SUCCESSFULLY RETRIEVED USING A BALLOON. TEN MORE JAGWIRE GUIDEWIRES WERE OPENED AND DURING PREPARATION, THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE PROCEDURE WAS COMPLETED USING THE THIRTEENTH JAGWIRE GUIDEWIRE. 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
    456976 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556581 16080735

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR