BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER

    MDR report key: 19893790 · Received August 2, 2024

    Report

    Report Number
    2124215-2024-47719
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERICARDIAL EFFUSION, HYPERTENSION, TACHYCARDIA, CHEST PAIN, PULMONARY EDEMA AND STRIDOR SYMPTOMS. AFTER COMPLETING A PULSED FIELD ABLATION (PFA) PROCEDURE WITH A FARAWAVE PULSED FIELD ABLATION CATHETER TO TREAT AN ATRIAL FIBRILLATION AND AN OFF-LABEL POSTERIOR WALL ABLATION THE PATIENT WAS FINE AND KEPT IN OBSERVATION POST PROCEDURE. AFTER TWO HOURS, THE PATIENT BECAME HYPERTENSIVE AND TACHYCARDIC, WITH CHEST AND BACK PAIN. AN X-RAY WAS PERFORMED THAT SHOWED CONCERNS OF LARYNGEAL NARROWING AND PULMONARY EDEMA, PNEUMOTHORAX WAS RULED OUT. AN ECHOCARDIOGRAM WAS PERFORMED AND AN EFFUSION WAS ALSO RULED OUT INITIALLY. THE PATIENT WAS THEN GIVEN FENTANYL, BENADRYL AND DECADRON. THE PATIENT WAS THEN INTUBATED AND SENT FOR A FULL BODY CT SCAN THAT SHOWED CONCERNS FOR AN ESOPHAGEAL PERFORATION AND A SMALL PERICARDIAL EFFUSION. THE PHYSICIAN THEN GAVE THE PATIENT COLCHICINE AND WAS LEFT INTUBATED OVER NIGHT. THE PATIENT WAS EXTUBATED THE NEXT DAY WITHOUT PAIN OR SYMPTOMS OF PERICARDITIS. TIKOSYN WAS GIVEN AND THE PATIENT WAS DISCHARGED AND IS DOING WELL. THE DEVICE IS NOT EXPECTED TO RETURN FOR LABORATORY ANALYSIS AS IT WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958890 FARAWAVE PULSED FIELD ABLATION CATHETER CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O| H