BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA DIAGNOSTIC CATHETERS

    MDR report key: 3063290 · Received April 11, 2013

    Report

    Report Number
    1628221-2013-00004
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K943739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED DEVICE WAS RETURNED FOR EVAL. THE DEVICE WAS VISUALLY EXAMINED AND THE COMPLAINT IS NOT CONFIRMED AS THE RETURNED DEVICE IS FULLY INTACT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE RETURNED DEVICE WAS DAMAGED, FLATTENED, AND KINKED JUST BELOW THE FUZE ZONE. THE TIP IS SLIGHTLY ELONGATED, APPROX. 4CM IN LENGTH NEAR THE DISTAL END OF THE RADIUSED TIP. THERE IS A BULGE IN THE TIP TUBING APPROX. 2MM DISTAL OF THE FUZE ZONE. THE TIP IS FULLY ATTACHED. MERIT IS UNABLE TO DETERMINE AN EXACT ROOT CAUSE FOR THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING AN AORTIC ANGIOGRAPHIC PROCEDURE THE CATHETER TIP BROKE OFF IN THE PATIENT. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156785 PERFORMA DIAGNOSTIC CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E246742

    Patients

    Seq Age Sex Outcome Treatment
    1 AORTIC STENT| ULTRAVIST CONTRAST