BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE CATHETER

    MDR report key: 22378913 · Received July 1, 2025

    Report

    Report Number
    2029046-2025-02148
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025460
    PMA / PMN Number
    P240006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 24-JUN-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A VARIPULSE¿ CATHETER AND A THERMOCOOL SMARTTOUCH® SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. TOWARDS THE END OF THE CASE, AFTER ABLATION WAS ALREADY COMPLETED WITH BOTH THE VARIPULSE¿ CATHETER AND THERMOCOOL SMARTTOUCH® SF CATHETER, A DROP ON BLOOD PRESSURE WAS DISCOVERED AND THE CARDIAC TAMPONADE WAS CONFIRMED BY ECHO; THE DOCTOR USED ULTRASOUND PROBE TO LOCATE THE PERICARDIAL EFFUSION. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS MOVED TO CRITICAL CARE UNIT (CCU) OVERNIGHT FOR RECOVERY. PATIENT WAS STABLE THE NEXT DAY. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE, OR ENTANGLEMENT WHICH MAY LEAD TO VALVULAR DAMAGE AS PART OF JOHNSON & JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A VARIPULSE¿ CATHETER AND A THERMOCOOL SMARTTOUCH® SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. TOWARDS THE END OF THE CASE, AFTER ABLATION WAS ALREADY COMPLETED WITH BOTH THE VARIPULSE¿ CATHETER AND THERMOCOOL SMARTTOUCH® SF CATHETER, A DROP ON BLOOD PRESSURE WAS DISCOVERED AND THE CARDIAC TAMPONADE WAS CONFIRMED BY ECHO; THE DOCTOR USED ULTRASOUND PROBE TO LOCATE THE PERICARDIAL EFFUSION. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS MOVED TO CRITICAL CARE UNIT (CCU) OVERNIGHT FOR RECOVERY. PATIENT WAS STABLE THE NEXT DAY. THE PHYSICIAN SAID IT COULD HAD BEEN ANY OF THREE AREAS WHERE HE ABLATED: CORONARY SINUS WITH RADIOFREQUENCY (RF), SEPTAL WALL OF RIGHT ATRIUM (RA) WITH RF, OR SUPERIOR VENA CAVA (SVC) WITH RF AND PULSED FIELD ABLATION (PFA). ACTIVATED CLOTTING TIME (ACT) WAS 345. NO TRANSSEPTAL PUNCTURE WAS DONE, EVERYTHING WAS DONE INSIDE THE RA. SEDATION USED WAS WHAT THEY CALL "DEEP SEDATION", PATIENT DID NOT HAVE GENERAL ANESTHESIA, PATIENT WAS NOT INTUBATED DURING PROCEDURE. THEY USED REGULAR FLOW RATE SETTINGS FOR THE THERMOCOOL SMARTTOUCH® SF CATHETER AND 30ML FOR IRRIGATION WITH VARIPULSE CATHETER DURING ABLATION. ALL FORCE VISUALIZATION FEATURES WERE USED WITH THE THERMOCOOL SMARTTOUCH® SF CATHETER. THEY USED IMPEDANCE RANGE 0-10 OHMS TO COLOR THE VISITAGS. THE PARAMETERS FOR THE VISITAGS WERE 3S,3MM,25% AND 3G. NO ERRORS WERE OBSERVED DURING APPLICATION OF ENERGY (RF OR PF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069216 VARIPULSE CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 31541363L 10846835025460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| H CARTO 3.| DECANAV CATHETER.| NGEN RF GENERATOR.| THMCL SMTCH SF BID, TC, D-F.| TRUPULSE GENERATOR.| ULTRASOUND PROBE.| UNK_CARTO VIZIGO SHEATH.| WEBSTER QUADRAPOLAR CATHETER.