BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 24755538 · Received April 1, 2026

    Report

    Report Number
    2029046-2026-01068
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 1, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025460
    PMA / PMN Number
    P240006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31682295L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 PULMONARY VEIN ISOLATION (PVI) ABLATION WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND THE PATIENT EXPERIENCED OXYGEN DESATURATION / BRONCHIAL SPASM THAT REQUIRED IV STEROIDS, NEBULIZER, AND CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE). WHEN DOLING A VARIPULSE PRO PROCEDURE, EVERYTHING WORKED OUT FINE AT THE BEGINNING. AFTER THE 3 ABLATIONS AT THE LEFT SUPERIOR PULMONARY VEIN (LSPV) THE OXYGEN SATURATION DROPPED. IT SEEMED TO HAVE BEEN A BRONCHI SPASM. AFTER GIVING STEROID IV AND A NEBULISOR, IT WAS CONTROLLABLE AND THEY COULD MOVE ON WITH THE OTHER VEINS. THEY ALSO GAVE A CPAP MASK TO BETTER BE ABLE TO WORK ON. NO OTHER ISSUES. PATIENT WAS BREATHING NORMALLY AFTER WAKING UP AFTER THE PROCEDURE. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PATIENT CONDITION. THE PHYSICIAN SAID THAT WITH THOSE KIND OF PATIENTS, HE HAD THIS ISSUE ALREADY WITH PFA. "REALLY RARE, BUT IT CAN HAPPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818704 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 31682295L 10846835025460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L