BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR PTFE-NITINOL GUIDEWIRE

    MDR report key: 3932205 · Received July 14, 2014

    Report

    Report Number
    3005099803-2014-02421
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OF DISTAL TIP DETACHED EXPOSING COREWIRE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS 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 PERCUTANEOUS NEPHROLITHOTRIPSY. THE EXACT DATE IS UNKNOWN BUT IT HAS BEEN REPORTED THAT THIS HAPPENED SOMETIME IN APRIL OR MAY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A METALLIC NEEDLE WAS USED WITH THE GUIDEWIRE. THE HYDROPHILIC DISTAL TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE FRAGMENT REMAINS IN THE PATIENT AND PLANS FOR ITS RETRIEVAL IS STILL TO BE DECIDED. ANOTHER PERCUTANEOUS NEPHROLITHOTRIPSY PROCEDURE IS ALSO PLANNED AT A LATER DATE. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE AT THE CONCLUSION OF THE PROCEDURE. THE WERE NO PATIENT COMPLICATIONS AND THE PATIENT HAS BEEN DISCHARGED. 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
    409198 SENSOR PTFE-NITINOL GUIDEWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0066703050

    Patients

    Seq Age Sex Outcome Treatment
    1