BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 22018087 · Received May 14, 2025

    Report

    Report Number
    2124215-2025-30950
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. IT WAS NOT AVAILABLE BECAUSE DEVICE WAS DISCARDED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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 THE PATIENT DEVELOPED PERICARDITIS POST PROCEDURE AND WAS ADMITTED INTO THE HOSPITAL FOR AN EXTRA DAY. THE PATIENT UNDERWENT BOTH THE PULSED FIELD ABLATION (PFA) AND WATCHMAN PROCEDURES SIMULTANEOUSLY. THE PATIENT HAD MENTIONED THAT THE CARDIO PHYSICIAN STATED THE PERICARDITIS WAS DUE TO THE PFA PROCEDURE. THE PATIENT IS CURRENTLY ON NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, ACETYLSALICYLIC ACID 81 MG, AND PRADAXA. THE PATIENT CANNOT LAY FLAT DUE TO THE PAIN IN HIS CHEST AND HAD SHORTNESS OF BREATH. THE PATIENT WAS ADVISED TO CALL 911 IF SEVERE SHORTNESS OF BREATH OR PAIN APPEARS. ADDITIONALLY, THE PATIENT REPORTED THE CARDIO PHYSICIAN STATED THE PULSING MUST HAVE SOMEHOW HIT THE HOT SACK THAT CAUSED INFLAMMATION. THE PATIENT MENTIONED EXPERIENCING NERVE PAIN IN THE T4 REGION AND WAS UNSURE OF THE CAUSE OF HIS OVERALL PAIN. TO ALLEVIATE HIS DISCOMFORT, THEY ADMINISTERED A STRONG MEDICATION THROUGH HIS IV, WHICH PROVIDED SOME RELIEF. THE PATIENT IS GRADUALLY IMPROVING AFTER TAKING THE PREVIOUSLY MENTIONED MEDICATIONS. THE PATIENT REPORTS THAT THERE IS NO FOLLOW-UP OR PLAN CURRENTLY IN PLACE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880877 FARAWAVE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Required Intervention| H