BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 23813907 · Received December 16, 2025

    Report

    Report Number
    2029046-2025-04163
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 16, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025460
    PMA / PMN Number
    P240006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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

    DURING ATYPICAL FLUTTER ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND A VARIPULSE¿ BI-DIRECTIONAL CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DROP AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. THE PATIENT WAS TRANSFERRED TO MEDICAL ICU WITH PERICARDIAL DRAIN IN FOR FURTHER OBSERVATION. THE ABLATION CATHETER WAS PULLED BACK TO THE RIGHT ATRIUM, AND THE PATIENT'S BLOOD PRESSURE DROPPED. INTRACARDIAC ECHO SHOWED THAT THERE WAS A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 1000CC FLUID WAS REMOVED. THE PROCEDURE WAS ABORTED. THE PATIENT WAS TRANSFERRED TO MEDICAL ICU IN STABLE CONDITION WITH THE PERICARDIAL DRAIN IN FOR FURTHER OBSERVATION. AFTER THE PFA (PULSE FIELD ABLATION) APPLICATIONS THE PHYSICIAN USED THE STSF CATHETER TO "TOUCH UP" AREAS FROM A PREVIOUS PROCEDURE. RF (RADIOFREQUENCY) LESIONS WERE APPLIED TO THE ANTERIOR MITRAL LINE, THE ANTERIOR SIDE OF THE RIDGE, AND THE BASE OF THE LEFT ATRIAL APPENDAGE. THE PHYSICIAN ABLATED USING THE DRAG TECHNIQUE; 25-35 WATTS MOVING THE CATHETER EVERY 6-7 OHM DROP IN IMPEDANCE. THERE WAS ONE LESION THAT DROPPED 12 OHMS AT THE BASE OF THE APPENDAGE. THE PHYSICIAN STATED THAT THE EFFUSION WAS MOST LIKELY CAUSED BY PERFORATION OF THE APPENDAGE. THE DEVICES USED FOR THE PROCEDURE WERE STSF D/F CURVE (D134805, LOT UNKNOWN), VARIPULSE 8.5 FR CATHETER (D141201; LOT UNKNOWN), SOUNDSTAR GE CATHETER 8FR (10439236; LOT UNKNOWN) OCTARAY D CURVE 2-2-2-2-2 MM SPACING CATHETER (D-1609-04; LOT UNKNOWN), VIZIGO MEDIUM CURL SHEATH (D138502; LOT UNKNOWN), DECANAV D CURVE CATHETER (R7D282CT; LOT UNKNOWN), CARTO SYSTEM, TRUPULSE GENERATOR, NGEN GENERATOR, AND BAYLESS TRANSEPTAL WIRE (NON-BWI DEVICE). ALL PRODUCTS WERE DISCARDED AND NOT AVAILABLE FOR RETURN. THERE ARE TWO REPORTS FOR THIS EVENT FOR THE STSF AND VARIPULSE CATHETERS. THIS REPORT IS FOR THE VARIPULSE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282514 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 10846835025460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R 7FR DECAN,11P,D,2.4MMLE,282MM,| 8.5F SHEATH WITH CURVE VIZ MDC| CARTO SOFTWARE| NGEN GENERATOR| OCTA,STD,48P,2-2-2-2-2,F-CURVE| SOUNDSTAR ECO GE 8F CATHETER| TRUPULSE GENERATOR