BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 24576648 · Received March 11, 2026

    Report

    Report Number
    2124215-2026-13751
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    July 2, 2025
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (LITERATURE). IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ARTICLE CITATION: GHAJAR, A., UZUNOGLU, E. C., LOPES, J., ASSIS, F., NEKKANTI, R., POPESCU, S. S., TILZ, R., SHANTHA, G., & CATANZARO, J. N. (2025). SEVERE HEMOLYSIS AFTER MODERATE-DOSE PULSED FIELD APPLICATION (48 PULSES) FOR ATRIAL FIBRILLATION/FLUTTER: A CAUTIONARY TALE. JACC. CASE REPORTS, 30(27), 105136. HTTPS://DOI.ORG/10.1016/J.JACCAS.2025.105136. D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. THIS WAS NOT AVAILABLE BECAUSE THIS WAS RELATED TO A LITERATURE STUDY. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    A KIDNEY INJURY, DYSPNEA AND HEMOLYSIS OCCURRED. IT WAS REPORTED AS PER LITERATURE ARTICLE THAT A 69-YEAR-OLD, AFRICAN AMERICAN MAN UNDERWENT ATRIAL FIBRILLATION/FLUTTER ABLATION WITH MODERATE DOSE PFA (48 PULSES) AND DEVELOPED SIGNIFICANT NEAR-DIALYSIS OLIGURIC ACUTE KIDNEY INJURY (AKI), REQUIRING A PROLONGED HOSPITAL STAY. GENERAL ANESTHESIA WITH PARALYTICS WAS USED. RIGHT ATRIAL AND LEFT ATRIAL ACTIVATION AND THREE-DIMENSIONAL MAPPING WERE PERFORMED. INTRACARDIAC MAPPING AND ELECTROCARDIOGRAMS REVEALED ATRIAL FLUTTER ORIGINATING FROM THE LEFT ATRIUM. MEDIUM DOSE PULSED FIELD ABLATION (PFA) WAS DELIVERED WITH 32 PULSES (EACH PULSE 2.0 KV) USING FARAPULSE (BOSTON SCIENTIFIC), AND ALL 4 PULMONARY VEINS WERE ISOLATED WITH FIRST PASS. THE ENTRANCE AND EXIT BLOCKS WERE CONFIRMED. THE POSTERIOR WALL WAS ISOLATED USING LINEAR ABLATION LINES (ROOF AND FLOOR LINES), EACH WITH 8 PFA PULSES (16 PULSES, EACH 2.0 KV) (FIGURE 2). A TOTAL OF 48 PFA PULSES WERE USED. FLUOROSCOPY, INTRACARDIAC ECHOCARDIOGRAPHY, AND INTRACARDIAC ELECTROGRAMS WERE USED TO ASSESS OPTIMAL TISSUE CONTACT BEFORE EACH ENERGY DELIVERY. NO INTRAOPERATIVE HYPOTENSION OCCURRED. VENOUS ACCESS TO CLOSURE TIME WAS 75 MINUTES. HEPARIN WAS ADMINISTERED WITH ACTIVATED CLOTTING TIME MORE THAN 300 SECONDS DURING THE PROCEDURE. POST-PROCEDURE ELECTROCARDIOGRAM SHOWED SINUS RHYTHM. FOLLOWING THE PROCEDURE, THE PATIENT RECEIVED INTRAVENOUS FLUID RESUSCITATION FOR A FEW HOURS; HOWEVER, IT WAS COMPLICATED BY DYSPNEA AND CLINICAL SIGNS OF VOLUME OVERLOAD. CONSEQUENTLY, INTRAVENOUS FLUIDS WERE DISCONTINUED, DIURETIC THERAPY WAS INITIATED, AND A SODIUM BICARBONATE INFUSION WAS STARTED AND CONTINUED FOR THE NEXT FEW DAYS. BLADDER SCANS WERE ROUTINELY PERFORMED AND DID NOT SHOW ANY URINARY RETENTION. BY DAY 5, CREATININE PEAKED AT 9.2 MG/DL AND BEGAN TO IMPROVE, MARKING THE TRANSITION TO A POLYURIC PHASE, DURING WHICH DIURETIC THERAPY WAS NO LONGER REQUIRED. THE DOWNTREND IN CREATININE CONTINUED ON DAYS 6 AND 7, AND THE PATIENT WAS DISCHARGED ON DAY 7. ARTICLE CITATION: GHAJAR, A., UZUNOGLU, E. C., LOPES, J., ASSIS, F., NEKKANTI, R., POPESCU, S. S., TILZ, R., SHANTHA, G., & CATANZARO, J. N. (2025). SEVERE HEMOLYSIS AFTER MODERATE-DOSE PULSED FIELD APPLICATION (48 PULSES) FOR ATRIAL FIBRILLATION/FLUTTER: A CAUTIONARY TALE. JACC. CASE REPORTS, 30(27), 105136. HTTPS://DOI.ORG/10.1016/J.JACCAS.2025.105136.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222930 FARAWAVE NO MATCH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1