BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREBSET

    MDR report key: 2232354 · Received September 2, 2011

    Report

    Report Number
    2134812-2011-00011
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    June 29, 2011
    Report Date
    September 1, 2011
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K081846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GREBSET MICRO-INTRODUCER KIT WAS USED FOR A PROCEDURE THAT IS OUTSIDE THE MANUFACTURER'S INDICATIONS FOR USE . THE GREBSET MICRO-INTRODUCER KIT IS INTENDED TO FACILITATE THE PERCUTANEOUS PLACEMENT OF GUIDEWIRES IN THE VASCULAR SYSTEM AND FOR DELIVERY OF CONTRAST MEDIA TO VASCULAR SITES. THE EXACT CAUSE OF FAILURE IS UNDETERMINALBLE. THE GREBSET WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONCLUSION OR ADMISSION BY VASCULAR SOLUTIONS, INC., THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE DEVICE FAILED OR MALFUNCTIONED IN ANY MANNER OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OF ANY PERSON.

    Description of Event or Problem · 1

    DURING A NEPHROSTOMY TUBE PLACEMENT, A 4CM SEGMENT OF THE GREBSET MICRO-INTRODUCER KIT GUIDEWIRE DETACHED AND REMAINED IN THE PATIENT'S KIDNEY. FOLLOWING THE PROCEDURE, THE PATIENT WAS TREATED FOR SEPSIS. A NEPHROLITHOTOMY WAS PERFORMED TWO WEEKS LATER AND THE 4CM SEGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREBSET DIAGNOSTIC INTRAVASCULAR CATHETER DQO VASCULAR SOLUTIONS, INC. 7951 552836

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R