BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLO HEMOSTASIS CATHETER

    MDR report key: 1170647 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04609
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K953338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 AN OPTIFLO HEMOSTASIS CATHETER DEVICE WAS USED ON THE SAME DAY. ACCORDING TO THE COMPLAINANT, PRIOR TO USE, THE NEEDLE DID NOT RETRACT. THERE IS NO FURTHER INFORMATION REGARDING THE OUTCOME OF THE PATIENT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLO HEMOSTASIS CATHETER KOG BOSTON SCIENTIFIC CORPORATION M00511751 0000605147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK