BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

    MDR report key: 5100260 · Received September 24, 2015

    Report

    Report Number
    2134070-2015-00047
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 4, 2015
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    PMA / PMN Number
    K043453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISPOSED OF BY THE CUSTOMER, IT WILL NOT BE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ASD CLOSURE, A PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED BY ICE. CALLER REPORTED THAT PROTAMINE WAS ADMINISTERED TO THE PATIENT AND THE EFFECT OF HEPARIN WAS REVERSED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. UPON REQUEST FOR ADDITIONAL INFORMATION, IT WAS REPORTED THAT IT WAS NOT THOUGHT THAT THE ICE CATHETER CAUSED THE EFFUSION. IT WAS ASSUMED THAT THE GORE DEVICE OR THE SHEATH FOR THE GORE DEVICE CAUSED THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631411 REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. ACU10135936 1861721

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention