BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS

    MDR report key: 24700449 · Received March 26, 2026

    Report

    Report Number
    2029046-2026-00983
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    January 30, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. 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 PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A WEBSTER CS CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND DRAIN PLACEMENT. DURING THE PROCEDURE, A CARDIAC PERFORATION WAS NOTED WHICH RESULTED IN A PERICARDIOCENTESIS BEING PERFORMED. THE PVC PROCEDURE WAS IN BOTH THE LEFT AND RIGHT VENTRICLES. A WEBSTER CS CATHETER WAS PLACED AND ADVANCED ANTERIORLY TO SEE IF THERE WERE ANY EARLY VENTRICULAR SIGNALS. THE TACTIFLEX CATHETER WITH THE AGILIS SHEATH WERE INTRODUCED INTO THE RIGHT VENTRICLE TO MAP THE PVC BUT NO EARLY POINTS WERE FOUND. THUS, IT WAS DECIDED TO MAP THE LEFT VENTRICLE. THE LEFT VENTRICLE WAS ACCESSED VIA FEMORAL ARTERY. THE ABLATION CATHETER WAS THEN INTRODUCED INTO THE LEFT VENTRICLE AND IT WAS HARD TO GET TO THE TARGET AREA, SO IT WAS DECIDED TO GO TRANSSEPTAL TO ACCESS THE LEFT VENTRICLE. AFTER TRANSSEPTAL ACCESS, THE LEFT VENTRICLE WAS MAPPED AND AN EARLY AREA WAS FOUND AND ABLATED. THE PVC WENT AWAY. A SECONDARY PVC WAS OBSERVED AND IT WAS DECIDED TO ATTEMPT TO FIND IT. THIS PVC WAS MAPPED ON THE RIGHT SIDE AND THEN THE LEFT. IT WAS DECIDED IT WAS A PERINODAL PVC ORIGINATING NEAR THE HIS. THE AORTIC CUSP AREA WAS ABOUT TO BE CHECKED FOR SIGNALS WHEN IT WAS NOTICED THAT THE PVC WAS GONE AND THE SINUS HEART RATE HAD INCREASED. USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE), IT WAS THEN OBSERVED THAT THERE WAS A MODERATE EFFUSION BEHIND THE RIGHT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED TO VACATE THE EFFUSION. THE PATIENT STABILIZED AND WAS SENT TO THE INTENSIVE CARE UNIT (ICU). LATER THE PATIENT HAD TO COME BACK TO PLACE A DIFFERENT KIND OF DRAIN AND THEN LEFT THE LAB IN STABLE CONDITION. THE PHYSICIAN STATED AFTER THE PROCEDURE THAT THIS HAPPENED ON THE RIGHT SIDE OF THE HEART BUT WAS UNSURE OF WHAT CAUSED IT OR WHEN IT OCCURRED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. IF THE PHYSICIAN HAD TO GUESS, IT HAPPENED ON THE RIGHT SIDE OF THE HEART AND NOT RELATED TO THE ABLATION CATHETER. POSSIBLY THE NON-ABBOTT CS PLACEMENT (BIOSENSE WEBSTER D135303) AS IT WENT VERY DISTAL. THE PATIENT IS FULLY RECOVERED. ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331758 WEBSTER CS CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1