BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUREATE HYDROPHILIC GUIDE WIRE

    MDR report key: 2934515 · Received January 11, 2013

    Report

    Report Number
    9616662-2013-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K092303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - THE EVALUATION HAS NOT BEEN COMPLETED. THE USER 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. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A BILIARY DRAINAGE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY GETTING THE WIRE THROUGH A PREVIOUSLY PLACED STENT. THE PHYSICIAN STATED THAT THE STENT HAD BEEN POORLY PLACED MAKING THE PROCEDURE MORE DIFFICULT. WHEN THE WIRE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE COATING MATERIAL ON THE END OF THE WIRE HAD SHEARED OFF. THE PHYSICIAN STATED THAT THIS WOULD HAVE OCCURRED WITH ANY WIRE SINCE HE WAS HAVING SUCH A DIFFICULT TIME GETTING THE WIRE THROUGH THE STENT. THE PHYSICIAN DOES NOT PLAN TO RETRIEVE THE COATING MATERIAL. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19149 LAUREATE HYDROPHILIC GUIDE WIRE WIRE, GUIDE, CATHETER DQO MERIT MEDICAL SYSTEMS, INC. K312585

    Patients

    Seq Age Sex Outcome Treatment
    1