BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 21647544 · Received March 19, 2025

    Report

    Report Number
    2029046-2025-00843
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025460
    PMA / PMN Number
    P240006
    Removal / Correction Number
    3013300026-01/17/2025-00
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 31511925L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 08-APR-2025. IT WAS INDICATED THAT THE NUMBER OF ABLATIONS PERFORMED WAS 78 IN TOTAL. BOTH RADIOFREQUENCY (RF) AND PULSED FILED ABLATION (PFA) ENERGY WAS PERFORMED: SIXTY (60) RF APPLICATIONS QMODE+, QMODE 400 AI POSTERIOR, QMODE 550 AI ANTERIOR (ROOF LINE, POSTERIOR LINE, AND LEFT INFERIOR PULMONARY VEIN). SIX (6) PFA APPLICATIONS USING VARIPULSE ON THE POSTERIOR WALL. TWELVE (12) RF APPLICATIONS USING QMODE (CTI). THERE WERE NO APPLICATIONS IN THE VEINS, ONLY ON THE ANTRAL REGION OF THE LEFT INFERIOR VEIN (ON THE POSTEROINFERIOR SIDE). THE FOLLOWING ABLATIONS WERE PERFORMED OUTSIDE THE PULMONARY VEINS: SIX (6) PFA (POSTERIOR WALL/BOX), TWELVE (12) RF CAVO-TRICUSPID ISTHMUS (CTI), 60 RF (ROOF LINE, POSTERIOR LINE, AND LEFT INFERIOR PULMONARY VEIN). PATIENT INFORMATION SECTION WAS UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED. FIELDS A 3A. SEX, A 3B. GENDER, A 5. ETHNICITY WERE UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REDO PULMONARY VEIN ISOLATION (PVI) AND ATYPICAL FLUTTER ABLATION, AND THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT. 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 31511925L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IT WAS CONFIRMED THAT ABLATION WAS PERFORMED OUTSIDE PULMONARY VEINS (6 PFA APPLICATIONS USING VARIPULSE ON THE POSTERIOR WALL). THE USE OF THE VARIPULSE¿ ABLATION CATHETER FOR ABLATIONS BEYOND PULMONARY VEIN ISOLATION MAY BE LINKED TO THE HIGHER-THAN-ANTICIPATED INCIDENCE OF PERI-PROCEDURAL STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA). IN 70% OF THE CASES OF STROKE OR TIA REPORTED TO BWI WORLD-WIDE, PATIENTS RECEIVED ABLATIONS OUTSIDE THE PULMONARY VEINS. THE SAFETY AND EFFECTIVE USE OF THIS DEVICE OUTSIDE OF THE PULMONARY VEINS FOR THE TREATMENT OF ATRIAL FIBRILLATION HAS NOT BEEN CLINICALLY ESTABLISHED AND MAY INCREASE THE RISK OF PATIENT INJURY. INTERNAL ACTION IS BEING FOLLOWED TO INVESTIGATE NEUROVASCULAR EVENTS WITH VARIPULSE CATHETERS. IMPORTANTLY, THE MECHANISM FOR AN INCIDENCE OF STROKE IS MULTI-FACTORIAL. THE INVESTIGATION ALSO CONCLUDED THAT THE RISK OF NEUROVASCULAR EVENTS MAY INCREASE IF A HIGH NUMBER OF ABLATIONS, STACKING OF ABLATIONS AND/OR ABLATION OUTSIDE OF THE PULMONARY VEINS ARE DELIVERED. THE INSTRUCTIONS FOR USE ARE INSTRUCTIONS THAT PROVIDE DETAILED GUIDANCE ON HOW SAFELY AND EFFECTIVELY USE A MEDICAL DEVICE. IT IS THE PHYSICIAN¿S RESPONSIBILITY TO REVIEW THE PATIENT¿S MEDICAL HISTORY AND MAKE THE BEST-INFORMED DECISION BASED ON ALL AVAILABLE INFORMATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REDO PULMONARY VEIN ISOLATION (PVI) AND ATYPICAL FLUTTER ABLATION, AND THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT. THIS PROCEDURE WAS A REDO PVI, WHERE THE VEINS WERE ALREADY ISOLATED AND A POSTERIOR BOX (ROOF-LINE AND POSTERIOR-LINE IN LEFT ATRIUM) WAS MADE. ABLATION WAS PERFORMED WITH THE QDOT CATHETER. THE POSTERIOR BOX COULD NOT BE ISOLATED. THE RECONNECTION WAS IN VERY CLOSE VICINITY OF THE ESOPHAGUS. MULTIPLE REMAPS AND RADIOFREQUENCY (RF)-APPLICATIONS WERE DONE WITH MULTIPLE CATHETER EXCHANGES THROUGH THE VIZIGO SHEATH. BECAUSE THE BOX COULD NOT BE ISOLATED USING THE QDOT WITH RF ABLATION, THE PHYSICIAN DECIDED TO USE VARIPULSE WITH PULSED FIELD ABLATION (PFA) TECHNOLOGY TO ISOLATE THE BOX, DUE TO CONCERNS ABOUT ESOPHAGEAL INJURY WITH RF. SIX PFA APPLICATIONS WERE GIVEN INSIDE (THE LOWER PART OF) THE BOX AND LEFT INFERIOR PULMONARY VEIN. THE BOX WAS ISOLATED, AND PROCEDURE FINISHED. THE ACTIVATED CLOTTING TIME (ACT) WAS MONITORED AND ABOVE 350 DURING THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SOME LOSS OF STRENGTH AND ORIENTATION IN RIGHT ARM AND LEG. PATIENT WAS THEN DIAGNOSED WITH CEREBROVASCULAR ACCIDENT CVA. CLINICAL SITUATION IS IMPROVING. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION TO MONITOR CVA SYMPTOMS. PROCEDURAL ACT WAS: FIRST ACT 285 -> 4000 EXTRA HEPARINE, BEFORE ABLATION 354, AFTER 30 MINUTES 322, AFTER 30 MINUTES 331, AFTER 30 MINUTES 289, EXTRA 3000 HEPARINE AND EXTRA 2000 HEPARINE 340, AFTER 15 MINUTES 357 THAN VARIPULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640769 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 31511925L 10846835025460

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Life Threatening| H 6FR CS,D,10 POLE,12 PIN,AUTOID.| 8.5F SHEATH WITH CURVE VIZ MDC.| FIX 6F,4P,F,SD,5MM,10PN-DR,115.| NGEN POWER SUPPLY.| OCTA,LNG,48P,2-5-2-5-2,D-CURVE.| QDOT MICRO, UNI, TC , D.| SMARTABLATE IRR TUBE SET.| SMARTABLATE IRR TUBE SET.| TRUPULSE GENERATOR.