BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERICARDIOCENTESIS KIT

    MDR report key: 1203479 · Received October 17, 2008

    Report

    Report Number
    1628221-2008-00023
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    July 23, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED TO MERIT FOR EVAL. VISUAL AND X-RAY EXAMINATION WERE PERFORMED AND MEASUREMENTS WERE TAKEN. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE PROXIMAL END OF THE WIRE HAD BEEN CUT. THE PART OF THE WIRE THAT WAS RETURNED WAS FOUND TO BE WITHIN SPECIFICATION DIMENSIONALLY. A WIRE FROM INVENTORY WAS TESTED IN AN ATTEMPT TO SIMULATE THE FAILURE MODE. THE WIRE FUNCTIONED NORMALLY WHEN USED WITH THE RETURNED CATHETER. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO SPECIFICATION DEVIATIONS WERE NOTED FOR THIS KIT. ALTHOUGH, THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED, THE NATURE OF THE PROCEDURE AND, THE LEVEL OF CLEARANCE BETWEEN THE CATHETER AND THE WIRE CAN BE CONTRIBUTING FACTORS IN THIS FAILURE TYPE. CORRECTIVE MEASURES HAVE BEEN TAKEN TO ELIMINATE THE POTENTIAL FOR REOCCURRENCE OF FAILURES OF THIS TYPE. A SMALLER DIAMETER GUIDE WIRE IS NOW BEING PROVIDED WITH THE CATHETER KIT. OTHER, MEASUREMENTS TAKEN, X-RAY, DEVICE HISTORY RECORD REVIEWED, DEVICE FROM A DIFFERENT LOT WAS TESTED. RESULTS: OTHER, DIMENSIONALLY WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERICARDIOCENTESIS PROCEDURE, THE WIRE WAS DIFFICULT TO REMOVE. THE PHYSICIAN WAS ABLE TO REMOVE THE WIRE AND THE CATHETER REMAINED IN PLACE. UPON REMOVAL OF THE WIRE, IT WAS NOTED THAT THE WIRE HAD BROKEN. THE WIRE WAS CUT IN ORDER TO CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERICARDIOCENTESIS KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. NA F567467

    Patients

    Seq Age Sex Outcome Treatment
    1