BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3010621 · Received March 19, 2013

    Report

    Report Number
    2029046-2013-00035
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3: MODEL# M-4800-01, SERIAL # (B)(4). COOLFLOW PUMP: MODEL# M-5491-02, SERIAL # UNKNOWN. STOCKERT: MODEL# M-5463-01, SERIAL # (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ABLATING IN THE HIS REGION, FAST JUNCTIONAL BEATS WERE OBSERVED DURING RF. THE CATHETERS WERE REPOSITIONED AFTER THE ABLATION AND COMPLETE HEART BLOCK WAS OBSERVED. NO UNDERLYING VENTRICULAR RHYTHM WAS OBSERVED. THE PATIENT WAS SUPPORTED WITH PACING AND MEDICATION UNTIL A TEMPORARY PACING DEVICE AND ISUPREL INFUSION WERE INSERTED. INTERMITTENT SECONDARY HEART BLOCK WAS OBSERVED PRIOR TO SENDING THE PATIENT TO CICU. PACING MANEUVERS WERE UTILIZED TO DIAGNOSE AND VERIFY AVNRT. THE PHYSICIAN INSERTED THE MAPPING/ABLATION CATHETER AND HIS REGION OF THE RIGHT ATRIUM WAS TAGGED WHEN ANY HIS SIGNAL WAS OBSERVED ON THE ABLATION CATHETER. ANATOMY OF THE CORONARY SINUS OSTIUM (CS OS) AND VALVE WAS ANNOTATED AS WELL WITH FAM. THE PHYSICIAN BEGAN ABLATING IN THE REGION OF THE SLOW PATHWAY. SEVERAL LESIONS WERE PLACED WITHOUT JUNCTIONAL BEATS OBSERVED. THE PHYSICIAN CONTINUED TO MOVE THE CATHETER MORE SUPERIOR TO THE INITIAL ABLATION LESION AND TOWARDS THE HIS "CLOUD". A MORE LEFT WARD MOVEMENT OF THE CATHETER RESULTED IN A SERIES OF ACCELERATED JUNCTIONAL BEATS AND ABLATION WAS STOPPED. THE PHYSICIAN PROCEEDED TO TEST FOR TACHYCARDIA USING PACING MANEUVERS. AVNRT WAS ONCE AGAIN INDUCED. THE PHYSICIAN REINSERTED THE ABLATION CATHETER AND VERIFIED THAT NO HIS SIGNAL WAS ON THE ABLATOR AS HE MOVED MORE SUPERIOR WITHIN THE SLOW PATHWAY AREA PLACING LESIONS. FOR A BRIEF MOMENT CATHETER STABILITY WAS LOST AND THE ABLATION CATHETER APPEARED ON THE CARTO MAP ON TOP OF ANNOTATED HIS POINTS. ABLATION WAS STOPPED AND THIRD DEGREE HEART BLOCK WAS OBSERVED. THE PATIENT HAD SECOND DEGREE HEART BLOCK UPON LEAVING THE LAB. PHYSICIAN OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS PROCEDURE-RELATED. THE EVENT RESULTED IN MODERATE IMPAIRMENT OF BODY FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114255 NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-08-S UNKNOWN_D-1183-08-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R