BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQWIRE® DIAGNOSTIC GUIDE WIRE

    MDR report key: 20131244 · Received September 3, 2024

    Report

    Report Number
    9616662-2024-00030
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 29, 2024
    Manufacturer
    MERIT MEDICAL IRELAND LTD
    Product Code
    DQX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE COMPLAINT DATABASE AND DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT AT THE START OF THE PROCEDURE, THE PATIENT HAD A TINY EFFUSION, WHICH THE CLINICIAN WAS NOT WORRIED ABOUT. THE CASE WAS GOING WELL, THERE WERE NO ISSUES WITH THE TRANSEPTAL. THE PROCEDURE CONTINUED TO INSERTING THE FARAPULSE CATHETER AND ROSEN WIRE TO ATTEMPT TO WIRE THE LSPV FOR ABLATIONS. THE CLINICIAN HAD A FELLOW WORKING WITH THEM WHO WAS MANIPULATING THE WIRE WHILE THE CLINICIAN MANIPULATED THE CATHETER. THE FELLOW INSERTED THE WIRE TO TRY TO WIRE THE LSPV, BUT INSTEAD WIRED THE APPENDAGE. THEY PULLED BACK AND TRIED AGAIN AND GOT APPENDAGE AGAIN. THE CLINICIAN TOLD THEM QUICKLY TO PULL THE WIRE BACK. WHEN THE WIRE WAS PULLED BACK IT THEN FELL INTO THE LSPV, AND THE PATIENT'S LEFT ATRIAL PRESSURE IMMEDIATELY BEGAN TO DECLINE FROM 100 DOWN TO 60 RAPIDLY. THE CLINICIAN CHECKED ON ICE AND SAW A BIG EFFUSION. THE PATIENT EXPERIENCED PERICARDIAL CENTICIS AND CARDIAC TAMPONADE. A CATH CLINICIAN CAME IN QUICKLY AND BEGAN TO DRAIN THE PRESSURE WITH A BAG. TWO BAGS WERE FILLED, AND THE PATIENT WAS STILL BLEEDING. SURGICAL BACKUP WAS CALLED AND THEY GOT A ROOM AND TEAM ON STANDBY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108006 INQWIRE® DIAGNOSTIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX MERIT MEDICAL IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L