BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ COOK 0.035 J GUIDEWIRE

    MDR report key: 17765073 · Received September 15, 2023

    Report

    Report Number
    MW5145731
    Event Type
    Injury
    Date Received
    September 15, 2023
    Report Date
    July 26, 2023
    Manufacturer
    COOK MEDICAL LLC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER EXHIBITED A STUCK GUIDEWIRE, AND THE PATIENT EXPERIENCED A CARDIAC TAMPONADE. DURING A FARAPULSE ELECTROPORATION PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION A FARAWAVE PULSED FIELD ABLATION CATHETER WAS SELECTED FOR USE. THE LEFT PULMONARY VEINS WERE ABLATED, BUT THERE WAS DIFFICULTY POSITIONING THE GUIDEWIRE IN THE RIGHT INFERIOR PULMONARY VEIN (RIPV) AND DEPLOYING THE CATHETER TO BASKET SHAPE DUE TO PATIENT ANATOMY. SOME RESISTANCE WAS FELT, AND IT WAS FOUND THE GUIDEWIRE WAS STUCK IN THE CATHETER. BY PUSHING THE GUIDEWIRE SLOWLY, BOTH THE GUIDEWIRE AND THE CATHETER WERE REMOVED FROM THE PATIENT. NO ISSUE WAS OBSERVED WITH THE CATHETER, BUT THE AMPLATZ COOK 0.035 J GUIDEWIRE WAS DAMAGED. THE GUIDEWIRE WAS REPLACED TO CONTINUE THE PROCEDURE. AT THE END OF THE PROCEDURE A SMALL TAMPONADE WAS OBSERVED. THE TAMPONADE WAS STOPPED VIA DRAINAGE AND THE PATIENT WAS ADMINISTERED PROTAMINE, AND THE PATIENT IS EXPECTED TO FULLY RECOVER. THE PROCEDURE WAS COMPLETED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84321 AMPLATZ COOK 0.035 J GUIDEWIRE WIRE, GUIDE, CATHETER DQX COOK MEDICAL LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown