BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPRESS ANGIOGRAPHIC CATHETERS

    MDR report key: 3060366 · Received April 11, 2013

    Report

    Report Number
    1628221-2013-00005
    Event Type
    Injury
    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
    K053171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USE SUSPECT DEVICE WAS RETURNED FOR EVAL. THE USER DID NOT INDICATE IF THIS WAS THE INITIAL USE OF THE DEVICE. THE DETACHED TIP WAS NOT INCLUDED WITH THE RETURNED CATHETER. 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 AND MAGNIFIED INSPECTION, THE COMPLAINT WAS CONFIRMED. THE TIP TUBING OF THE CATHETER IS DETACHED AT THE FUZE ZONE JUNCTION. THERE IS EVIDENCE OF GOOD MELT FLOW THE ENTIRE CIRCUMFERENCE OF THE BODY TUBING AT THE FUZE ZONE. THE REMAINING TIP MATERIAL IS VERY JAGGED AND GIVES THE APPEARANCE THE TIP WAS TORN AWAY FROM THE BODY TUBING. THERE IS A KINK APPROX 59.4 CM FROM THE DISTAL END OF THE STRAIN RELIEF. A REVIEW OF ALL PRODUCTION SET UP SAMPLES INDICATE SAMPLES EXCEEDED TENSILE TEST REQUIREMENTS. 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 TIP OF THE CATHETER BROKE OFF IN THE PT. NO ADDITIONAL INFO HAS BEEN PROVIDED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155487 IMPRESS ANGIOGRAPHIC CATHETERS CATHETER, INTRAVASCULAR, DIGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E367643

    Patients

    Seq Age Sex Outcome Treatment
    1 ULTRAVIST CONTRAST| AORTIC STENT