BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 FR RAP FEMORAL VENOUS CANNULA

    MDR report key: 1211203 · Received October 24, 2008

    Report

    Report Number
    2953686-2008-00003
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ESTECH
    Product Code
    DWF
    PMA / PMN Number
    K052081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FAILURE INVESTIGATION WAS COMPLETED ON THE 22 FR RAP FV CANNULA. THE RETURNED PRODUCT HAD SEPARATED INTO SEVERAL PARTS, MOST LIKELY FALLING UNDER TENSION. PULL TESTS WERE COMPLETED ON SEVERAL CANNULAE AND THE FAILED UNIT. THE TENSILE FORCE AT FAILURE AVERAGED 20 LBS. IT CONCLUDED THE ROOT CAUSE OF THE FAILURE WAS EXCESSIVE TENSILE FORCE APPLIED TO THE CANNULA. THE FIELD REPORT DID NOTE THE DOCTOR HAD TO APPLY MORE FORCE THAN USUAL TO REMOVE THE CANNULA.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT DURING A MINIMALLY INVASIVE MITRAL VALVE REPAIR PROCEDURE, THE DOCTOR HAD TO APPLY MORE FORCE THAN USUAL TO REMOVE THE DISLODGED 22 FR VENOUS CANNULA. IT SEPARATED IN TWO PLACES WHILE PULLING OUT. ALL PIECES WERE RECOVERED. THE PT HAD LARGE HEMATOMA IN THE GROIN AREA. X-RAYS WERE TAKEN AND THE PT APPEARS TO BE DOING FINE. THE HOSPITAL REP INDICATED SHE DIDN'T FEEL THE PT COMPLICATIONS WERE CAUSED BY OR LINKED TO THE PRODUCT MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 22 FR RAP FEMORAL VENOUS CANNULA 22 FR RAP FV CANNULA DWF ESTECH 200-100 WO 1888

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization