BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR PTFE-NITINOL GUIDEWIRE

    MDR report key: 4003794 · Received August 12, 2014

    Report

    Report Number
    3005099803-2014-02754
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OF DISTAL TIP DETACHED. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR PTFE-NITINOL GUIDEWIRE WAS USED DURING A CYSTOSCOPY AND URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A METALLIC NEEDLE WAS USED WITH THE GUIDEWIRE. THE HYDROPHILIC DISTAL TIP OF THE GUIDEWIRE WAS DETACHED EXPOSING THE TIP OF THE METAL CORE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS SCHEDULED TO COME BACK WITHIN THE WEEK TO HAVE THE FRAGMENTS REMOVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478568 SENSOR PTFE-NITINOL GUIDEWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0066703090 16794560

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR