BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLASHWIRE¿ GUIDE WIRE

    MDR report key: 20081529 · Received August 27, 2024

    Report

    Report Number
    9616662-2024-00029
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 23, 2024
    Report Date
    August 23, 2024
    Manufacturer
    MERIT MEDICAL IRELAND LTD
    Product Code
    DQX
    UDI-DI
    00884450529447
    PMA / PMN Number
    K201595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE IS ATTRIBUTED TO CLINICAL USE AND EXCESSIVE FORCE DURING USE. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THE WIRE COATING AND THE WIRE TIP DETACHED WITHIN A BALLOON THAT WAS USED IN THE PATIENT. BOTH THE WIRE AND BALLOON WERE REMOVED TOGETHER AS A UNIT. NO INTERVENTION NEEDED. A NEW WIRE WAS USED TO COMPLETE THIS PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128012 SPLASHWIRE¿ GUIDE WIRE WIRE, GUIDE, CATHETER DQX MERIT MEDICAL IRELAND LTD K2888189 00884450529447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown