BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA VESSEL SIZING CATHETERS

    MDR report key: 2222955 · Received August 10, 2011

    Report

    Report Number
    1628221-2011-00037
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K000659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVAL. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. 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. UPON VISUAL INSPECTION, NO DEFECTS IN THE RETURNED DEVICE WERE FOUND. THE RETURNED UNIT WAS THEN PERFORMANCE TESTED. TESTING RESULTS REVEALED A LEAK UNDERNEATH THE STRAIN RELIEF. CUSTOMER COMPLAINT WAS CONFIRMED. THE HUB WAS THEN SPLIT OPEN AND EXAMINED UNDER MAGNIFICATION. A FRACTURE WAS FOUND IN THE BODY MATERIAL AND THE STRAIN RELIEF DIRECTLY BELOW THE DISTAL END OF THE HUB. THE ROOT CAUSE OF THE REPORTED FAILURE IS LIKELY DUE TO EXCESSIVE ADHESIVE APPLIED TO THE CATHETER DURING MFG. THIS IS BELIEVED TO BE AN UNUSUAL EVENT. EVALUATION METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE FLUSHING THE CATHETER, A LEAK WAS NOTICED AROUND THE HUB. ANOTHER CATHETER WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA VESSEL SIZING CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E242874

    Patients

    Seq Age Sex Outcome Treatment
    1