BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR UROLOGICAL GUIDEWIRE

    MDR report key: 3810391 · Received May 14, 2014

    Report

    Report Number
    3005099803-2014-01820
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT UPN AND DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED EVENT OF DISTAL TIP DETACHED EXPOSING THE 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 SENSOR UROLOGICAL GUIDEWIRE WAS USED DURING A UROLOGICAL PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE SURGEON FELT SOME RESISTANCE UPON MOVING THE GUIDEWIRE INTO THE CANNULA OF THE OLYMPUS SHORT RIGID URETEROSCOPE. THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE FRAGMENTS WERE REMOVED FROM THE PATIENT¿S BODY THROUGH SUCTIONING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THE CONDITION OF THE PATIENT WAS REPORTED TO BE STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288819 SENSOR UROLOGICAL GUIDEWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK391

    Patients

    Seq Age Sex Outcome Treatment
    1