BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2202457 · Received August 5, 2011

    Report

    Report Number
    1721504-2011-00239
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DRE
    PMA / PMN Number
    K073035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVAL. UPON VISUAL INSPECTION, THE COMPLAINT WAS CONFIRMED. A TEAR WAS SEEN IN THE INTRODUCER SHEATH. 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 FURTHER INVESTIGATION OF THE RETURNED DEVICE, A MARK WAS NOTICED ON THE DILATOR RETURNED WITH THE SHEATH. THIS MARK INDICATES THAT THE TWO PARTS WERE ASSEMBLED WHEN THE DAMAGE OCCURRED. MERIT IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. NO CONCLUSION CAN BE DRAWN. EVAL METHOD: DEVICE HISTORY WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED. RESULTS: UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A VENOUS LASER ABLATION PROCEDURE, THE INTRODUCER SHEATH TORE APPROX 3 CM FROM THE TIP OF THE SHEATH. THE TEAR WAS NOTICED BY THE CUSTOMER AT THE END OF THE PROCEDURE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DRE MERIT MEDICAL SYSTEMS, INC. H226126

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| CONTRAST MEDIA