BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_VARIPULSE

    MDR report key: 22958231 · Received September 3, 2025

    Report

    Report Number
    2029046-2025-02902
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    April 24, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    PMA / PMN Number
    P240006
    Removal / Correction Number
    3013300026-01/17/2025-00
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MIYAZAKI S, KAWAMURA I, IWASA Y, NEGISHI M, TATEISHI R, HONDA M, GOTO K, NISHIMURA T, YAMAO K, TAO S, TAKIGAWA M, SASANO T. DIFFERENT INCIDENCE AND SIZE OF SILENT STROKES AFTER PULSED FIELD ABLATION WITH CIRCULAR SHAPED ABLATION CATHETERS. CIRC ARRHYTHM ELECTROPHYSIOL. 2025 MAY;18(5): E013719. DOI: 10.1161/CIRCEP.125.013719. EPUB 2025 APR 24. PMID: 40270255. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MIYAZAKI S, KAWAMURA I, IWASA Y, NEGISHI M, TATEISHI R, HONDA M, GOTO K, NISHIMURA T, YAMAO K, TAO S, TAKIGAWA M, SASANO T. DIFFERENT INCIDENCE AND SIZE OF SILENT STROKES AFTER PULSED FIELD ABLATION WITH CIRCULAR SHAPED ABLATION CATHETERS. CIRC ARRHYTHM ELECTROPHYSIOL. 2025 MAY;18(5):E013719. DOI: 10.1161/CIRCEP.125.013719. EPUB 2025 APR 24. PMID: 40270255. BACKGROUND: PULSED FIELD ABLATION (PFA) IS A NOVEL NONTHERMAL ABLATION MODALITY THAT MINIMIZES ESOPHAGEAL DAMAGE. THUS, THE LEFT ATRIAL POSTERIOR WALL IS OFTEN TARGETED IN ADDITION TO PULMONARY VEINS. OBJECTIVE: THIS IS THE FIRST STUDY TO DIRECTLY COMPARE THE SILENT STROKE RISK BETWEEN DIFFERENT PFA SYSTEMS UNDER IDENTICAL CONDITIONS. METHODS: THIS SINGLE-CENTER STUDY INCLUDED 16 PATIENTS WITH CONSECUTIVE ATRIAL FIBRILLATION WHO UNDERWENT PULMONARY VEIN ISOLATIONS (PVIS) WITH PFA FROM JUNE TO SEPTEMBER 2024. PVIS AND SUBSEQUENT LEFT ATRIAL POSTERIOR WALL ISOLATIONS (LAPWIS) WERE PERFORMED IN ALL WITH VARIABLE-LOOP IRRIGATED CIRCULAR CATHETERS (VLCCS; VARIPULSE, BIOSENSE WEBSTER) AND CARTO (WITH TISSUE PROXIMITY INDICATION TECHNOLOGY)1 OR OVER-THE-WIRE TYPE CIRCULAR MULTIELECTRODE ARRAY CATHETERS (CMACS; PULSESELECT; MEDTRONIC) WITH ENSITE.2 ALL WERE PERFORMED BY A SINGLE EXPERIENCED OPERATOR(S.M.; RADIOFREQUENCY >1500; CRYOBALLOON >1000) TO MINIMIZE THE PROCEDURAL IMPACT ON THE RESULTS. ALL PATIENTS GAVE THEIR WRITTEN INFORMED CONSENT. THE STUDY WAS APPROVED BY THE HOSPITAL¿S INSTITUTIONAL REVIEW BOARD. CONCLUSIONS: MOST ACUTE ASYMPTOMATIC LESIONS POST-RADIOFREQUENCY ABLATION REPORTEDLY HEAL WITHOUT SCARRING5; HOWEVER, FURTHER MRI FOLLOW-UP EVALUATION IS NECESSARY. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: (VLCCS; VARIPULSE, BIOSENSE WEBSTER). OTHER BWI PRODUCTS: CARTO MAPPING SYSTEM AND SHEATH (11.5-FR CARTOVIZIGO). NON-BWI DEVICES: OVER-THE-WIRE TYPE CIRCULAR MULTIELECTRODE ARRAY CATHETERS (CMACS; PULSE SELECT; MEDTRONIC) WITH ENSITE, TISSUE PROXIMITY INDICATION TECHNOLOGY, SHEATH (14-FR FLEX CATH CONTOUR). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: PATIENT A HAS 15 SCES/SCLS INCLUDING A 21-MMSIZED LESION IN THE LEFT PARIETAL LOBE. NO INTERVENTION MENTIONED. QTY 1: PATIENT B HAD 14 SCES/SCLS INCLUDING A 13-MM-SIZED LESION IN THE RIGHT FRONTAL LOBE.. NO INTERVENTION MENTIONED. QTY 1: PATIENT C HAD 3 SCES/SCLS INCLUDING A 10-MM-SIZED LESION IN THE RIGHT CEREBELLUM. NO INTERVENTION MENTIONED. QTY 1: PATIENT D THE PATIENT HAD 30 SCES/SCLS INCLUDING A 5-MM-SIZED LESION IN THE RIGHT FRONTAL LOBE. NO INTERVENTION MENTIONED. QTY 1: PATIENT E HAD 12 SCES/SCLS INCLUDING A 5-MM-SIZED LESION IN THE RIGHT PARIETAL LOBE. NO INTERVENTION MENTIONED. QTY 1: PATIENT F HAD 3 SCES/SCLS INCLUDING A 4-MM-SIZED LESION IN THE RIGHT FRONTAL LOBE. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331972 UNKNOWN_VARIPULSE PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CMACS CATHETERS.| ENSITE SYSTEM.| PULSE SELECT, MEDTRONIC CATHETERS.| SHEATH (14-FR FLEX CATH CONTOUR).| UNK_CARTO 3.| UNK_CARTO VIZIGO SHEATH.