BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQWIRE DIAGNOSTIC GUIDE WIRE

    MDR report key: 12046720 · Received June 22, 2021

    Report

    Report Number
    9616662-2021-00011
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 3, 2021
    Report Date
    May 27, 2021
    Manufacturer
    MERIT MEDICAL IRELAND LTD
    Product Code
    DQX
    UDI-DI
    00884450196373
    PMA / PMN Number
    K133230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. IF PRODUCT RETURNS AT A LATER DATE THIS REPORT WILL BE REOPENED AND A FULL INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT DURING A RADIAL APPROACH DIAGNOSTIC HEART CATH THE CARDIOLOGIST EXPERIENCED TROUBLE REMOVING THE DIAGNOSTIC CATHETER. THE INQWIRE GUIDE WIRE COULDN'T BE REMOVED FROM THE SHEATH. WHILE PULLING THE SHEATH AND WIRE OUT TOGETHER, THE TIP OF THE WIRE DETACHED IN THE RIGHT DISTAL RADIAL ARTERY. THE PATIENT WENT TO SECONDARY SURGERY INVOLVING RIGHT RADIAL EMBOLECTOMY, REMOVAL OF INTRA-ARTERIAL FOREIGN BODY, AND PRIMARY REPAIR OF THE ARTERY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936761 INQWIRE DIAGNOSTIC GUIDE WIRE DIAGNOSTIC GUIDE WIRE DQX MERIT MEDICAL IRELAND LTD K2041175 00884450196373

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R