BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 25237240 · Received May 20, 2026

    Report

    Report Number
    2029046-2026-01638
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 20, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025460
    PMA / PMN Number
    P240006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 31798766L 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. 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 PERSISTENT ATRIAL FIBRILLATION ABLATION WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND THE PATIENT EXPERIENCED HEMOLYSIS. HEMOLYSIS WAS OBSERVED ON THE DAY OF THE PROCEDURE, AND INTRAVENOUS FLUIDS WERE ADMINISTERED (500 ML OF SALINE SOLUTION). THE FLUIDS WERE DISCONTINUED THE FOLLOWING DAY, AND NO ABNORMALITIES, INCLUDING RENAL FUNCTION, WERE NOTED. THE PATIENT TOLERATED ORAL INTAKE WELL WITHOUT ISSUES. PATIENT FULLY RECOVERED. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN COMMENTED THAT THE EXCESSIVE NUMBER OF ABLATIONS MAY HAVE CONTRIBUTED TO THIS EVENT. THE PHYSICIAN COMMENTED THAT THERE HAD BEEN AREAS THAT HAD NOT BEEN IN CONTACT DURING ABLATION WITH VARIPULSE CATHETER, WHICH MAY HAVE CREATED GAPS AND HAD INCREASED THE NUMBER OF ABLATIONS. AND THAT, BECAUSE THE LEFT ATRIUM WAS LARGE AND THE FREQUENCY OF ELECTRICAL CONTACT WAS INEVITABLY HIGHER THAN USUAL DUE TO THE PATIENT'S FACTOR, IT MAY HAVE BEEN UNAVOIDABLE. A PATIENT WITH PERSISTENT ATRIAL FIBRILLATION UNDERWENT PVI (PULMONARY VEIN ISOLATION) WITH THE VARIPULSE CATHETER. AGILIS AND SL0 WERE PUNCTURED FROM THE GROIN. AFTER SOUNDFAM, XEROSTAR (JAPAN LIFELINE CO.) WAS ADVANCED AHEAD INTO THE SOUND AGILIS IN SL0 AND BB (BROCKENBROUGH METHOD, A TRANSSEPTAL PUNCTURE TECHNIQUE) WAS PERFORMED. AFTER BB, OCTARAY WAS ADVANCED INTO THE LEFT ATRIUM VIA AGILIS AND PRE MAPPING WAS PERFORMED; OCTARAY AND VARIPULSE CATHETER WERE THEN REPLACED AND ABLATION WAS STARTED. ABLATION WAS PERFORMED FROM THE LPV (LEFT PULMONARY VEIN), TOTAL OF 14 ABLATIONS IN LPV AND TOTAL OF 16 ABLATIONS IN RPV (RIGHT PULMONARY VEIN) WERE PERFORMED. AFTER ONE-ROUND ISOLATION, VARIPULSE CATHETER AND OCTARAY WERE REPLACED AND A POST MAPPING WAS PERFORMED. DURING POST MAPPING, RESIDUAL POTENTIALS WERE RECORDED IN LS (LEFT SUPERIOR) AND RI (RIGHT INFERIOR). CATHETER REPLACEMENT WAS PERFORMED AGAIN AND 4 ADDITIONAL ABLATIONS IN LS AND 2 ADDITIONAL ABLATIONS IN RS (RIGHT SUPERIOR) WERE PERFORMED. AN ADDITIONAL CATHETER REPLACEMENT WAS PERFORMED, AND LS RESIDUAL POTENTIALS WERE AGAIN RECORDED, SO 3 ADDITIONAL ABLATIONS WERE PERFORMED. THE FINAL NUMBERS OF ABLATIONS WERE 21 IN LPV 21 AND 18 IN RPV. VARIPULSE PLUS HAD BEEN INTRODUCED AND THERE WERE NO IRRIGATION FLOW ERRORS DUE TO HUMAN ERROR ETC. THE PHYSICIAN COMMENTED THAT THE PATIENT'S LARGE LEFT ATRIUM AND THE PERSISTENT/TOUGH POTENTIALS IN LS MAY HAVE BEEN FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314226 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 31798766L 10846835025460

    Patients

    Seq Age Sex Outcome Treatment
    1