BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA NASOBILIARY CATHETER

    MDR report key: 1192095 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05079
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K982508
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVAL, IT HAS NOT BEEN RECEIVED. THE DEVICE EVAL HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008 THAT A FLEXIMA NASOBILIARY CATHETER WAS USED ON TWO DAYS EARLIER. ACCORDING TO THE COMPLAINANT, WHILE REMOVING THE GUIDEWIRE FROM THE TARGET LESION, SOME RESISTANCE WAS FELT. WHEN THE GUIDEWIRE WAS REMOVED, THE PHYSICIAN NOTED THE COATING WAS PEELED IN THREE PLACES. THE PEELED COATING REMAINED INSIDE THE PT AND WAS VISIBLE UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH THIS FLEXIMA NASOBILIARY CATHETER. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA NASOBILIARY CATHETER FGE BOSTON SCIENTIFIC CORPORATION M00540120 11871265

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other