BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 21778589 · Received April 4, 2025

    Report

    Report Number
    2124215-2025-21045
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 8, 2025
    Report Date
    April 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZA
    UDI-DI
    00191506043193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN SECTION B2 OUTCOMES ATTRIB TO ADV EVENT, SECTION B5 DESCRIBE EVENT OR PROBLEM AND SECTION H6 IMPACT CODES. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 IN A DISRUPT-AF STUDY, THE PATIENT EXPERIENCED BLEEDING A FEW DAYS AFTER HAVING A PULSED FIELD ABLATION (PFA) PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS BLEEDING FROM HIS NOSE. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2025, STATING THAT THE NOSEBLEED HAD BEEN GOING ON FOR TWO TO THREE DAYS. THE PATIENT DOES WEAR OR USES SUPPLEMENTAL OXYGEN. ACCORDING TO THE HOSPITAL NOTE IT STATES THE PATIENT'S OXYGEN NASAL PRONGS TEND TO IRRITATE NASAL SEPTUM AND THEY BELIEVE THIS IS WHAT CAUSED THE NOSE TO BLEED. THERE WAS A LIMITED ECHO ON (B)(6) 2025 THAT WAS NORMAL WITH NO PERICARDIAL EFFUSION. EMERGENCY MEDICAL TECHNICIAN PACKED THE NOSE WITH GAUZE, WHICH RESOLVED THE NOSEBLEED. HEMOGLOBIN AND HEMATOCRIT LEVELS WERE NORMAL ON ARRIVAL AND THROUGHOUT THE STAY. THE PATIENT WENT TO AN EAR, NOSE, AND THROAT (ENT) SPECIALIST FOR A FOLLOW-UP ON (B)(6) 2025 AND UNDERWENT A NASAL SEPTAL CAUTERIZATION. THE PATIENT WAS ADMITTED FOR OBSERVATION DUE TO AN ELEVATED TROPONIN. THIS IS A NORMAL FINDING AFTER A CARDIAC ABLATION. TROPONINS CHECKED THROUGHOUT THE STAY AND CONTINUED TO TREND DOWN. NO TREATMENT DONE OR REQUIRED. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) EXACERBATION WHICH IS A CHRONIC ISSUE. PATIENT HAS A HISTORY OF WEARING OXYGEN AND IRRITATION IN THE NASAL SEPTUM AND HISTORY OF COPD. THE PATIENT DISCHARGED HOME ON (B)(6) 2025. THE PATIENT WAS SEEN ON (B)(6) 2025, AND THE FINAL SUMMARY NOTES INDICATES BILATERAL NOSEBLEEDS, WHICH ARE COMPOUNDED BY HIS COPD, USE OF NASAL PRONG OXYGEN, AND THE MEDICATION XARELTO. XARELTO WAS HELD FOR FIVE DAYS, ASPIRIN 81 MILLIGRAMS WERE STOPPED, AND THE PATIENT IS PLANNING TO UNDERGO A LEFT ATRIAL APPENDAGE OCCLUSION IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A DISRUPT-AF STUDY, THE PATIENT EXPERIENCED BLEEDING A FEW DAYS AFTER HAVING A PULSED FIELD ABLATION (PFA) PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001417 FARAWAVE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZA BOSTON SCIENTIFIC CORPORATION 00191506043193

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H| O