BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER?

    MDR report key: 3973121 · Received August 1, 2014

    Report

    Report Number
    3005099803-2014-02596
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DISTAL TIP DETACHED EXPOSING THE METAL COREWIRE TIP. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATHFINDER GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHILE INSERTING THE PATHFINDER GUIDEWIRE INTO THE CANNULA, THE NURSE ENCOUNTERED RESISTANCE. ATTEMPTS WERE MADE TO INSERT THE GUIDEWIRE FURTHER INTO THE CANNULA BUT WAS UNSUCCESSFUL. THE GUIDEWIRE WAS REMOVED FROM THE CANNULA AND THE HYDROPHILIC TIP OF THE PATHFINDER GUIDEWIRE DETACHED OUTSIDE THE PATIENT, EXPOSING THE TIP OF THE METAL COREWIRE. THE PROCEDURE WAS COMPLETED WITH A NEW PATHFINDER 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449799 PATHFINDER? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00551591 16467408

    Patients

    Seq Age Sex Outcome Treatment
    1