BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER EXCHANGE GUIDEWIRE

    MDR report key: 1171408 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04659
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OCY
    PMA / PMN Number
    K943737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (BENT TIP). ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A PATHFINDER EXCHANGE GUIDEWIRE DEVICE WAS USED EIGHT DAYS PRIOR. ACCORDING TO THE COMPLAINANT, AFTER FLUSHING SALINE INTO THE PROTECTIVE HOOP, THE DEVICE WAS REMOVED. IT WAS THEN NOTED THAT "THE TIP WAS BENT AND WAVED." THE PROCEDURE WAS COMPLETED WITH ANOTHER PATHFINDER EXCHANGE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE EVENT WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER EXCHANGE GUIDEWIRE OCY BOSTON SCIENTIFIC CORPORATION M00551591 11489795

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK