BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS

    MDR report key: 25053594 · Received April 30, 2026

    Report

    Report Number
    2029046-2026-01421
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    January 30, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: 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. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION WITH A WEBSTER CS CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. DURING THE PREMATURE VENTRICULAR CONTRACTIONS 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 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 INTENSIVE CARE UNIT. 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 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 CS CATHETER PLACEMENT AS IT WENT VERY DISTAL. THE PATIENT IS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183741 WEBSTER CS CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R