BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 24430592 · Received February 24, 2026

    Report

    Report Number
    3008452825-2026-00083
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 24, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067034656
    PMA / PMN Number
    P220013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT'S LOT NUMBER COULD NOT BE OBTAINED, THEREFORE THE PRIMARY DI NUMBER IS PROVIDED (D4), BUT FULL UDI INFORMATION IS NOT AVAILABLE. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE BATCH RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT OF A CARDIAC PERFORATION COULD NOT BE CONCLUSIVELY DETERMINED.

    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 PVC PROCEDURE WAS IN BOTH THE LEFT AND RIGHT VENTRICLES. A NON-ABBOTT CS CATHETER (BIOSENSE) 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 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 ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487488 TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿ Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation OAE ABBOTT MEDICAL A-TFSE-D 05415067034656

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention| H