BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARADRIVE

    MDR report key: 24563726 · Received March 10, 2026

    Report

    Report Number
    2124215-2026-13285
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    January 1, 2026
    Report Date
    March 10, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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. ARTICLE CITATION: ORBAN, G., BOGA, M., SALLO, Z., OSZTHEIMER, I., NAGY, K. V., PERGE, P., TANAI, E., CZUMBEL, B., BAKAN, B., KOMLOSI, F., TOTH, P., FERENCZ, A. B., MERKELY, B., GELLER, L., & SZEGEDI, N. (2025). COMPARISON OF ROOM TIMES BETWEEN PULSED-FIELD ABLATION AND VERY HIGH POWER SHORT-DURATION ABLATION. HEART RHYTHM O2, 6(10), 1546 TO 1555. HTTPS://DOI.ORG/10.1016/J.HROO.2025.07.008 PER STUDY NO SPECIFIC EVENT DATE WAS PROVIDED.

    Description of Event or Problem · 0

    PER LITERATURE REVIEW, IT WAS REPORTED THAT IT WAS CONDUCTED ADDITIONAL ANALYSIS EXCLUDING CASES WHERE ADDITIONAL ABLATION WAS PERFORMED 63 BEYOND PULMONARY VEIN ISOLATION (PVI). THIS MEANT THE EXCLUSION OF 24 PFA CASES. SIMILARLY 64 TO THE MAIN POPULATION, THE ONLY DIFFERENCE FOUND BETWEEN PVI ONLY PFA AND PVI ONLY VHPSD PATIENTS WAS THE PRIOR PVI, WHICH IS RELATED TO THE LOCAL INSURANCE POLICIES. AGAIN, IN LINE WITH THE MAIN POPULATION, NO SIGNIFICANT DIFFERENCES IN PULMONARY VEIN ANATOMY, STARTING RHYTHMS, OR MECHANISM OF SINUS RHYTHM RESTORATION BETWEEN PVI ONLY PFA AND PVI ONLY VHPSD GROUPS. DURING PFA PROCEDURES, SEDATION WAS PERFORMED AS DESCRIBED IN THE SEDATION PROTOCOL SECTION. THE FARAPULSE SYSTEM WAS USED FOR PFA IN OUR STUDY. OWING TO LOCAL INSURANCE POLICIES, SOME PFA CASES WERE REDO AF ABLATIONS. ALL REDO CASES INVOLVED THE REISOLATION OF ALL PVS AS PART OF THE STANDARDIZED PROTOCOL. SIMILAR TO THE RFA PROCEDURES, THE PROCEDURES WERE PERFORMED USING FEMORAL VENOUS ACCESS. IN CONTRAST, ONLY A SINGLE TRANSSEPTAL PUNCTURE WAS PERFORMED DURING PFA PROCEDURES. IN THE SAME MANNER AS FOR RFA, INTRAVENOUS HEPARIN WAS USED TO ACHIEVE A TARGET ACTIVATED CLOTTING TIME OF 350 SECONDS AFTER ACCESSING THE LA. THE FARAWAVE ABLATION CATHETER WAS INTRODUCED THROUGH THE FARADRIVE SHEATH INTO THE LA AND CONNECTED TO THE FARASTAR ABLATION GENERATOR. SUBSEQUENTLY, PVI WAS PERFORMED WITH PFA AS FOLLOWS: 4-4 APPLICATIONS IN BASKET AND FLOWER CONFIGURATIONS, WITH A 30 DEGREE CATHETER ROTATION AFTER 2 APPLICATIONS IN EACH CONFIGURATION. GIVEN THAT THERE WAS NO CONTACT FORCE FEEDBACK WITH THIS SYSTEM AT THE TIME OF THE STUDY, ICE AND FLUOROSCOPY WERE USED TO EVALUATE CATHETER-TISSUE CONTACT, POSITION, AND PV ANATOMY. AS STATED, A COMPLETE RE PVI WAS PERFORMED WITH PFA FOR REINFORCEMENT IN ALL REDO CASES. THEREFORE, ALL PFA CASES INVOLVED A FULL PVI. PFA WAS ALSO USED IN SOME CASES TO PERFORM ABLATION BEYOND PVI (POSTERIOR WALL, MITRAL ISTHMUS, ROOF ISOLATION, ETC) BASED ON THE INDIVIDUAL JUDGMENT OF THE OPERATING PHYSICIAN. ANESTHESIA WAS SUSPENDED AT THE START OF ABLATION OF THE LAST PV. ONCE AWAKE AND ASSESSED AS NEUROLOGICALLY INTACT, PATIENTS WERE TRANSFERRED TO THE INPATIENT WARD. ALL PATIENTS WITHOUT COMPLICATIONS WERE DISCHARGED THE DAY AFTER THE PROCEDURE. FOUR COMPLICATIONS OCCURRED DURING OUR STUDY WITHOUT A SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS. THERE WAS 1 GROIN HEMATOMA IN BOTH THE PFA AND VHPSD GROUPS THAT DID NOT REQUIRE FURTHER INTERVENTION. IN 1 PFA CASE, EXTENSIVE ST ELEVATION OCCURRED. CORONARY ANGIOGRAPHY WAS PERFORMED, WHICH DID NOT CONFIRM CORONARY ARTERY DISEASE, AND THE ST ELEVATION RESOLVED SPONTANEOUSLY WITHIN A FEW MINUTES WITHOUT RESIDUAL SYMPTOMS. THE PATIENT RESOLVED WITHOUT SEQUELAE AND WAS DISCHARGED THE NEXT DAY. ONE MAJOR COMPLICATION OCCURRED IN A PFA PATIENT WHO DEVELOPED AN ARTERIOVENOUS FISTULA AT THE SITE OF FEMORAL PUNCTURE, REQUIRING VASCULAR SURGERY THE DAY AFTER THE ABLATION. THERE WAS NO SIGNIFICANT DIFFERENCE IN HOSPITAL STAY BETWEEN GROUPS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (LITERATURE). ARTICLE CITATION: ORBAN, G., BOGA, M., SALLO, Z., OSZTHEIMER, I., NAGY, K. V., PERGE, P., TANAI, E., CZUMBEL, B., BAKAN, B., KOMLOSI, F., TOTH, P., FERENCZ, A. B., MERKELY, B., GELLER, L., & SZEGEDI, N. (2025). COMPARISON OF ROOM TIMES BETWEEN PULSED-FIELD ABLATION AND VERY HIGH POWER SHORT-DURATION ABLATION. HEART RHYTHM O2, 6(10), 1546 TO 1555. HTTPS://DOI.ORG/10.1016/J.HROO.2025.07.008

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617052 FARADRIVE VASCULAR GUIDE-CATHETER, SINGLE-USE DRA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention