BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY¿ STEERABLE EP CATHETER

    MDR report key: 16990983 · Received May 24, 2023

    Report

    Report Number
    2030404-2023-00033
    Event Type
    Injury
    Date Received
    May 24, 2023
    Report Date
    June 21, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    PMA / PMN Number
    K961924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION REMAINS UNKNOWN. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE HEART RHYTHM SOCIETY IN AN ARTICLE TITLED ¿DIAGNOSTIC DECAPOLAR CATHETER ENTRAPMENT IN THE CORONARY SINUS: A RARE COMPLICATION OF ELECTROPHYSIOLOGY PROCEDURES", SAMUEL J. TU, 2666-5018/© 2022. A PATIENT WITH RECURRENT PALPITATIONS WAS REFERRED FOR DIAGNOSTIC ELECTROPHYSIOLOGY STUDY. HOLTER MONITORING DEMONSTRATED PAROXYSMS OF ATRIAL TACHYCARDIA AND SYMPTOMS WERE REFRACTORY TO MEDICAL THERAPY. THERE WAS NO RELEVANT MEDICAL HISTORY, AND TRANSTHORACIC ECHOCARDIOGRAPHY WAS NORMAL. ELECTROPHYSIOLOGY STUDY WAS UNDERTAKEN UNDER SEDATION WITH INTRAVENOUS FENTANYL AND MIDAZOLAM. THE RIGHT FEMORAL VEIN WAS CANNULATED AND A 6-F STEERABLE DECAPOLAR CATHETER (INQUIRY MEDIUM CURVE) INTRODUCED INTO THE RIGHT ATRIUM. ONCE THE TIP WAS AT THE CORONARY SINUS (CS) OSTIUM, CATHETER ADVANCEMENT WAS NOT POSSIBLE DESPITE DEFLEXING AND FURTHER CLOCKWISE ROTATION, AND IT WAS SPECULATED THAT A THEBESIAN VALVE MAY BE OBSTRUCTING THE PASSAGE. THUS, A NON ABBOTT 7F STEERABLE ABLATION CATHETER (NAVISTAR THERMOCOUPLE D CURVE, BIO-SENSE WEBSTER INC, IRVINE, CA) WAS USED TO SUCCESSFULLY CANNULATE THE CS WITHOUT DIFFICULTY, DEMARCATING THE VENOUS ANATOMY AND VERTICAL CS COURSE. ATTEMPTS TO SIMULTANEOUSLY CANNULATE THE CS WITH THE DECAPOLAR CATHETER WERE NOT SUCCESSFUL, AND SO THE ABLATION CATHETER WAS REMOVED. THE DECAPOLAR CATHETER COULD SUBSEQUENTLY BE ADVANCED; HOWEVER, WITHDRAWAL OF THE CATHETER WAS MET WITH UNEXPECTED RESISTANCE, AND RETRACTION WAS ASSOCIATED WITH PAIN, ANXIETY, TACHYCARDIA, AND TRANSIENT HYPOTENSION. TRANSTHORACIC ECHOCARDIOGRAPHY WAS UNDERTAKEN WITH NO PERICARDIAL EFFUSION, NOR OBVIOUS CATHETER ENTRAPMENT WITHIN THE TRICUSPID VALVE APPARATUS OR CHIARI NETWORK SEEN. A LONG SHEATH (SWARTZ SR2, ABBOTT MEDICAL) WAS USED TO CANNULATE THE CS OSTIUM, AND VENOGRAPHY DEMONSTRATED THAT THE MIDPORTION OF THE CATHETER WAS ENTRAPPED VERY PROXIMALLY IN THE CS WITH OBSTRUCTION TO CONTRAST BEYOND THE POINT OF ENTRAPMENT. ADDITIONAL INTRAVENOUS SEDATION WAS ADMINISTERED TO RELIEVE DISCOMFORT AND ANY CONTRIBUTION FROM CS SPASM. ATTEMPTS WERE MADE TO NAVIGATE THE ABLATION CATHETER PAST THE OBSTRUCTION FROM BOTH FEMORAL AND RIGHT INTERNAL JUGULAR APPROACHES. GLYCERYL TRINITRATE WAS ADMINISTERED THROUGH THE SR2 SHEATH TO FURTHER REDUCE ANY SPASM COMPONENT. WHILE GENERAL ANESTHESIA WAS BEING CONSIDERED AND CARDIOTHORACIC SURGERY OPINION BEING SOUGHT, REPEATED COUNTERCLOCKWISE CATHETER ROTATIONS WERE FINALLY ABLE TO FREE THE CATHETER TIP AND IT WAS WITHDRAWN SUCCESSFULLY. THERE WAS NO VISIBLE TISSUE AROUND THE REMOVED CATHETER NOR OBVIOUS INDENTATION. A SMALL 1.1 CM PERICARDIAL EFFUSION WAS NOTED WITHOUT SYMPTOMS OR HEMODYNAMIC EFFECT ONE HOUR POST PROCEDURE. THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION AND DISCHARGED THE NEXT DAY ON ANTI-INFLAMMATORY MEDICATION. REPEAT ECHOCARDIOGRAPHY 1 WEEK LATER DEMONSTRATED COMPLETE RESOLUTION OF THE PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618843 INQUIRY¿ STEERABLE EP CATHETER ELECTRODE RECORDING CATHETER DRF ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention