BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 24115045 · Received January 20, 2026

    Report

    Report Number
    24115045
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 4, 2025
    Report Date
    December 29, 2025
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    QZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE ABLATION PROCEDURE, MULTIPLE CATHETERS WERE ATTEMPTED TO BE USED WITHOUT SUCCESS. THERE WAS NO REPORTED HARM TO THE PATIENT. THERE WERE THREE BIOSENSE WEBSTER VARIPULSE CATHETERS USED: CATHETER ISSUES RANGED FROM INABILITY TO DELIVER ENERGY OR A CATHETER SENSOR ERROR. ONE BIOSENSE WEBSTER STSF THERMOCOOL ABLATION CATHETER, ONE SOUNDSTAR DIAGNOSTIC ULTRASOUND AND, TWO INTERFACE CABLES WERE ALL DEEMED DEFECTIVE AND NOT USED. DEFECTIVE PRODUCTS: 8.5 FR VARIPULSE BI-DIRECTIONAL CATHETER - MODEL #: D141201; LOTS; 31735091L (2) & 31656561L. VARIPULSE CATH TO GENERATOR CBL STERILE - MODEL # D133701; LOT: F100003882 (2). 8FR THERMOCOOL SMARTTOUCH CATHETER ST SF, THERMOCOUPLE, DF CURVE, BI-DIRECTIONAL - MODEL #: D135805; LOT: 3173788L. 8F SOUNDSTAR ECO ULTRASOUND CATHETER - MODEL #: 10439236; LOT: G9531935. MANUFACTURER RESPONSE FOR INTRAVASCULAR CATHETERS, SEE REPORT DESCRIPTION (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175927 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BIOSENSE WEBSTER, INC. D141201 31735091L (2) & 31656561L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown