BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIWAVE ENDOVASCULAR SYSTEM

    MDR report key: 1011968 · Received March 11, 2008

    Report

    Report Number
    3003043897-2008-00001
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 11, 2008
    Product Code
    DQO
    PMA / PMN Number
    K071762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO OMNISONICS AND EVALUATED. THE DEVICE WIRE WAS FOUND TO BE FRACTURED AT THE TIP, HOWEVER, ALL PORTIONS OF THE WIRE REMAINED WITH THE DEVICE DUE TO THE CAPTURED TIP DESIGN. SEM IMAGES OF THE FRACTURE INDICATE EXTERNAL DAMAGE CAUSED THE FRACTURE, BUT ATTEMPTS TO RE-CREATE THE CONDITIONS WERE UNSUCCESSFUL AND THE EXACT CAUSE REMAINS UNKNOWN AND THIS REPORT IS INCONCLUSIVE.

    Description of Event or Problem · 1

    AN OMNIWAVE DEVICE WAS UTILIZED TO ABLATE A BILATERAL IF DVT DISEASE WITH GREATER THAN 14 DAY OLD SYMPTOMS. THE PATIENT HAD AN IVC FILTER. AFTER ACCESSING THROUGH THE LEFT SIDE ILIAC FEMORAL VEIN, THE OMNISONICS KIT WAS USED FOR 10 MINUTES. AFTER 10 MINUTES, IT WAS DECIDED TO STOP THE PROCEDURE AND ASSESS THE SITUATION WITH A VENOGRAM. THE CATHETER WAS EXAMINED AFTER IS WAS REMOVED. DURING THE EXAMINATION, IT WAS DISCOVERED THAT THE WAVEGUDIE (TITANIUM) WIRE HAD COME OUT OF THE CAPTURED TIP POCKET AND WAS STICKING OUT. IT WAS DECIDED NOT TO USE THE CATHETER FOR ADDITIONAL TREATMENT. THERE WERE NO UNTOWARD EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIWAVE ENDOVASCULAR SYSTEM CONTINUOUS FLUSH CATHETER DQO 01-2083 KV0008

    Patients

    Seq Age Sex Outcome Treatment
    1