BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPRESS ANGIOGRAPHIC CATHETERS

    MDR report key: 2193612 · Received July 14, 2011

    Report

    Report Number
    1628221-2011-00032
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K053171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CUSTOMER HAS NOT RELEASED THE DEVICE FOR EVAL. PHOTOGRAPHS OF THE SUSPECT DEVICE WERE PROVIDED BY THE CUSTOMER. UPON VISUAL EXAMINATION OF THE PICTURES TAKEN, THE COMPLAINT WAS CONFIRMED. THE CATHETER BODY TUBING HAD COMPLETELY SEPARATED FROM THE TIP TUBING AT THE FUSE ZONE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. MERIT IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE WITHOUT THE SUSPECT DEVICE. A F/U REPORT WILL BE SUBMITTED IF MORE INFO BECOMES AVAILABLE. METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED, PHOTOGRAPH OF THE SUSPECT DEVICE WAS EXAMINED. RESULTS: UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE WITHOUT THE SUSPECT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO INSERTION INTO THE PT, THE TIP OF THE CATHETER DETACHED WHEN A GUIDE WIRE WAS ADVANCED THROUGH THE BACK OF THE CATHETER. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFO OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. THEREFORE, THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPRESS ANGIOGRAPHIC CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E130295

    Patients

    Seq Age Sex Outcome Treatment
    1 3MM J TIP GUIDE WIRE