BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 24544703 · Received March 9, 2026

    Report

    Report Number
    2124215-2026-12814
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    July 30, 2025
    Report Date
    May 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DEVICE RETURN AVAILABILITY AND DETAILED PRODUCT INFORMATION COULD NOT BE RETRIEVED SINCE THE EVENT WAS REVIEWED FROM A LITERATURE STUDY. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. ONCE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    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. THE DEVICE RETURN AVAILABILITY AND DETAILED PRODUCT INFORMATION COULD NOT BE RETRIEVED SINCE THE EVENT WAS REVIEWED FROM A LITERATURE STUDY. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, ALTHOUGH THE PRODUCT WAS NOT RETURNED, IT WAS DETERMINED THAT THE BRAIN INJURY IS A KNOWN INHERENT RISK OF USE OF THIS DEVICE. DEVICE TECHNICAL ANALYSIS: IT WAS INDICATED THE DEVICE IS UNAVAILABLE FOR RETURN; THEREFORE, A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. LABELING REVIEW: THE DEVICE WAS USED FOR PERSISTENT ATRIAL FIBRILLATION; THIS IS CONSIDERED OFF-LABEL USE OF THE DEVICE. THE CATHETER IS INTENDED TO BE USED TO TREAT PAROXYSMAL ATRIAL FIBRILLATION (PAF), AND THIS PROCEDURE IS NOT CONSIDERED PART OF THE TREATMENT OF PAF. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE FARAWAVE DEVICE CONFIRMED THAT THE EVENT OF BRAIN INJURY AND USER USED INCORRECT PRODUCT FOR INTENDED USE ARE KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. PRODUCT RISK BENEFIT INCLUDES CONSIDERATION OF RISK SEVERITY AND RATE, AND THE OVERALL RESIDUAL RISK OF THE FARAWAVE DEVICE IS ACCEPTABLE. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT OF BRAIN INJURY IS A KNOWN INHERENT RISK OF THE FARAWAVE DEVICE. BRAIN INJURY IS CONSIDERED WITHIN THE RISK THRESHOLD FOR EMBOLISM. EMBOLISM IS AN EXPECTED PROCEDURAL COMPLICATION ADDRESSED WITHIN THE IFU FOR THE FARAWAVE CATHETER. THERE WERE NO ALLEGATIONS OF A DEVICE DEFICIENCY CONTRIBUTING TO THE REPORTED ADVERSE EVENT, AND THE DEVICE HAS NOT BEEN RETURNED TO BSC FOR ANALYSIS AT THIS TIME.

    Description of Event or Problem · 0

    PER LITERATURE REVIEW, IT WAS REPORTED THAT: IN THIS SINGLE-CENTER STUDY AT THE (B)(6) HOSPITAL OF VALENCIA BETWEEN (B)(6) 2022 AND (B)(6) 2023, FORTY-FIVE PATIENTS WITH SYMPTOMATIC PAROXYSMAL AND PERSISTENT ATRIAL FIBRILLATION UNDERWENT PULMONARY VEIN ISOLATION WITH PULSE FIELD ABLATION (PFA). AT 24 HOURS AFTER THE PROCEDURE, PATIENTS UNDERWENT A 1.5T BRAIN MAGNETIC RESONANCE IMAGING(MRI) SCAN TO DETECT NEW ISCHEMIC OR HEMORRHAGIC BRAIN LESIONS. AS A RESULT, THREE PATIENTS SHOWED NEW LESIONS ON THE BRAIN MRI SCAN. ONE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) WITH MIXED APHASIA, RECOVERING WITHIN THE NEXT 24 HOURS, AND TWO PATIENTS HAD SILENT CEREBRAL LESIONS (SCLS). PATIENTS WITH BRAIN LESIONS EXHIBITED A SIGNIFICANTLY LARGER LEFT ATRIAL VOLUME THAN THOSE WITHOUT LESIONS. IN THE 2 PATIENTS WITH SCL, LESION RESOLUTION WAS CONFIRMED ON THE FOLLOW-UP MRI SCAN. THE PATIENT WITH TIA HAD A LESION IN THE LEFT PARIETAL REGION ASSOCIATED WITH TRANSIENT MIXED APHASIA. HE WAS A 51-YEAR-OLD MAN WITH PERSISTENT AF DIAGNOSED IN 2022. CARDIOVERSION WAS PERFORMED DURING THE ABLATION. THE TOTAL PROCEDURE TIME WAS 105 MINUTES. IN 1 OF THE PATIENTS WITH SCL, A SINGLE LESION IN THE RIGHT SEMI-OVAL CENTER MEASURING 5 BY 4 MILLIMETER WAS DOCUMENTED. HE WAS A 64 YEAR OLD MAN WITH PERSISTENT ATRIAL FIBRILLATION DIAGNOSED IN 2022. THE OTHER PATIENT WITH SCL ON MRI SHOWED A SINGLE LESION IN THE RIGHT CEREBELLAR REGION MEASURING 6 B 4 MILLIMETER. SHE WAS A 71 YEAR OLD PATIENT WITH A HISTORY OF ISCHEMIC HEART DISEASE, DIAGNOSED WITH PAROXYSMAL ATRIAL FIBRILLATION. IN FOLLOW-UP, THE PATIENT WITH TIA REFUSED FURTHER CONTROL MRI SCANS. THE TWO PATIENTS WITH THE SCL UNDERWENT A NEW CEREBRAL MRI SCAN AT 90 DAYS, CONFIRMING IN THAT THE LESIONS HAD HEALED WITHOUT CHRONIC SCARRING. NO DEVICE IS EXPECTED TO RETURN AS THIS IS FROM A LITERATURE REVIEW.

    Description of Event or Problem · 0

    PER LITERATURE REVIEW, IT WAS REPORTED THAT: IN THIS SINGLE-CENTER STUDY AT THE UNIVERSITY CLINICAL HOSPITAL OF VALENCIA BETWEEN OCTOBER 2022 AND DECEMBER 2023, FORTY-FIVE PATIENTS WITH SYMPTOMATIC PAROXYSMAL AND PERSISTENT ATRIAL FIBRILLATION UNDERWENT PULMONARY VEIN ISOLATION WITH PULSE FIELD ABLATION (PFA). AT 24 HOURS AFTER THE PROCEDURE, PATIENTS UNDERWENT A 1.5T BRAIN MAGNETIC RESONANCE IMAGING(MRI) SCAN TO DETECT NEW ISCHEMIC OR HEMORRHAGIC BRAIN LESIONS. AS A RESULT, THREE PATIENTS SHOWED NEW LESIONS ON THE BRAIN MRI SCAN. ONE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) WITH MIXED APHASIA, RECOVERING WITHIN THE NEXT 24 HOURS, AND TWO PATIENTS HAD SILENT CEREBRAL LESIONS (SCLS). PATIENTS WITH BRAIN LESIONS EXHIBITED A SIGNIFICANTLY LARGER LEFT ATRIAL VOLUME THAN THOSE WITHOUT LESIONS. IN THE 2 PATIENTS WITH SCL, LESION RESOLUTION WAS CONFIRMED ON THE FOLLOW-UP MRI SCAN. THE PATIENT WITH TIA HAD A LESION IN THE LEFT PARIETAL REGION ASSOCIATED WITH TRANSIENT MIXED APHASIA. HE WAS A 51-YEAR-OLD MAN WITH PERSISTENT AF DIAGNOSED IN 2022. CARDIOVERSION WAS PERFORMED DURING THE ABLATION. THE TOTAL PROCEDURE TIME WAS 105 MINUTES. IN 1 OF THE PATIENTS WITH SCL, A SINGLE LESION IN THE RIGHT SEMI-OVAL CENTER MEASURING 5 BY 4 MILLIMETER WAS DOCUMENTED. HE WAS A 64 YEAR OLD MAN WITH PERSISTENT ATRIAL FIBRILLATION DIAGNOSED IN 2022. THE OTHER PATIENT WITH SCL ON MRI SHOWED A SINGLE LESION IN THE RIGHT CEREBELLAR REGION MEASURING 6 B 4 MILLIMETER. SHE WAS A 71 YEAR OLD PATIENT WITH A HISTORY OF ISCHEMIC HEART DISEASE, DIAGNOSED WITH PAROXYSMAL ATRIAL FIBRILLATION. IN FOLLOW-UP, THE PATIENT WITH TIA REFUSED FURTHER CONTROL MRI SCANS. THE TWO PATIENTS WITH THE SCL UNDERWENT A NEW CEREBRAL MRI SCAN AT 90 DAYS, CONFIRMING IN THAT THE LESIONS HAD HEALED WITHOUT CHRONIC SCARRING. NO DEVICE IS EXPECTED TO RETURN AS THIS IS FROM A LITERATURE REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122885 FARAWAVE NO MATCH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1