BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 24852497 · Received April 11, 2026

    Report

    Report Number
    2029046-2026-01179
    Event Type
    Injury
    Date Received
    April 11, 2026
    Date of Event
    March 7, 2026
    Report Date
    May 13, 2026
    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
    BE
    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 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PVI (PULMONARY VEIN ISOLATION) ABLATION AND THE PATIENT EXPERIENCED A STROKE AND REQUIRED PROLONGED HOSPITALIZATION. AFTER THE PROCEDURE ON (B)(6), "EVERYTHING WAS OK"; HOWEVER, THE PATIENT WAS READMITTED TO THE HOSPITAL BECAUSE HE COULD NOT SEE VERY WELL. PATIENT HAD A CT (COMPUTED TOMOGRAPHY) SCAN AND THEY SAW A SMALL STROKE, A SMALL INJURY IN THE VISUAL CORTEX. THE PATIENT WAS ADMITTED FOR A COUPLE OF DAYS. A REQUEST FOR FOLLOW-UP HAS BEEN MADE TO IDENTIFY THE SPECIFIC CATHETER USED DURING THE PROCEDURE. AT THIS TIME, THE EVENT IS BEING REPORTED AS A CONSERVATIVE MEASURE, UNDER VARIPULSE¿ BI-DIRECTIONAL CATHETER WITH AN UNKNOWN PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144323 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