BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 25248194 · Received May 21, 2026

    Report

    Report Number
    2029046-2026-01645
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    PMA / PMN Number
    P240006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO VARIPULSE¿ BI-DIRECTIONAL CATHETER APPROVED UNDER P240006. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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

    DURING A BWI-SPONSORED CLINICAL STUDY, IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND EXPERIENCED EDEMA VOLUME OVERLOAD. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS CAUSAL. THE ADVERSE EVENT IS EXPECTED/ANTICIPATED. THE OUTCOME WAS THAT THE PATIENT'S CONDITION RECOVERED/RESOLVED WITH AN END DATE OF (B)(6) 2026. INTERVENTION WAS MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564442 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1