BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORONARY SINUS CATHETER

    MDR report key: 24480812 · Received March 2, 2026

    Report

    Report Number
    MW5184533
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 25, 2026
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING THE PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, A CARDIAC PERFORATION WAS NOTED WHICH RESULTED IN A PERICARDIOCENTESIS BEING PERFORMED. THE PREMATURE VENTRICULAR CONTRACTION (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 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 (B)(6) 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-(B)(6) CS PLACEMENT (BIOSENSE WEBSTER (B)(6)) AS IT WENT VERY DISTAL. THE PATIENT IS FULLY RECOVERED. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553597 CORONARY SINUS CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown