BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILIS NXT INTRODUCER, 8.5F, LARGE CURL, 82CM

    MDR report key: 4023654 · Received August 1, 2014

    Report

    Report Number
    3005188751-2014-00084
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC (AF-MINNETONKA)
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR ANALYSIS WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED DEATH COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 3005188751-2014-00088, 3005188751-2014-00089, 2030404-2014-00077, 2030404-2014-00078, 2030404-2014-00079, 2184149-2014-00005. FOLLOWING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE, THE PATIENT EXPIRED. THIS HIGH RISK SUBSTRATE MODIFICATION VT ABLATION PROCEDURE IN THE LEFT VENTRICLE WAS PERFORMED ON AN ELDERLY MALE WITH SEVERE CARDIOMYOPATHY, A HISTORY OF LARGE LAD TERRITORY MYOCARDIAL INFARCTION, AND AN IMPLANTED CARDIAC PACEMAKER/DEFIBRILLATOR. THE PATIENT PRESENTED TO THE LAB IN A PACED RHYTHM AND ANESTHESIA WAS ADMINISTERED; THE PATIENT SUBSEQUENTLY BECAME HYPOTENSIVE. AN EPINEPHRINE INFUSION WAS INITIATED TO STABILIZE AND MAINTAIN BLOOD PRESSURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM GUIDANCE AND AN AGILIS NXT INTRODUCER WAS ADVANCED INTO THE LEFT ATRIUM. FOLLOWING THE TRANSSEPTAL PUNCTURE, A PERICARDIAL EFFUSION WAS NOTED; HOWEVER, THIS WAS NOT SIGNIFICANT AND THE PROCEDURE CONTINUED. A NON-SJM SCREW IN BIPOLAR PACING CATHETER WAS PLACED IN THE RIGHT VENTRICLE AND AN INQUIRY AFOCUS II EP CATHETER WAS ADVANCED INTO THE LEFT VENTRICLE. THE AFOCUS II EP CATHETER WAS USED TO MAP, BOTH TRANSSEPTAL AND VIA A RETROGRADE APPROACH. THE AFOCUS II EP CATHETER WAS DAMAGED AND THEN REPLACED TO CONTINUE MAPPING. DURING COMPLETION OF THE MAP, THE PATIENT DEVELOPED VT, RESULTING IN HEMODYNAMIC INSTABILITY; THEREFORE, THE PATIENT WAS CARDIOVERTED TO SINUS RHYTHM (SR). THE CATHETERS SHIFTED ON THE ENSITE VELOCITY MAPPING SYSTEM DUE TO THE CARDIOVERSION AND SETTINGS CHANGES. RE-MAPPING WAS COMPLETED AND THE AFOCUS II EP CATHETER WAS REPLACED WITH A TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER. CATHETER DISPLAY ISSUES WERE NOTED AND TROUBLESHOOTING WAS PERFORMED, EVENTUALLY RESOLVING THIS ISSUE. RE-MAPPING WAS PERFORMED AGAIN WITH THE TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER, WHICH WAS THEN REPLACED WITH A THERAPY COOL FLEX ABLATION CATHETER. ABLATION WAS SUCCESSFULLY PERFORMED AROUND A VERY LARGE SCAR WHICH STRETCHED FROM THE APEX TO THE BASE OF THE LEFT VENTRICLE. NEAR THE CONCLUSION OF THE PROCEDURE, THE ANESTHESIA TEAM NOTED IT WAS DIFFICULT TO MAINTAIN A STABLE BLOOD PRESSURE AND THE PERICARDIAL EFFUSION NOTED EARLIER HAD INCREASED IN SIZE. PROTAMINE WAS ADMINISTERED AND A PERICARDIAL DRAIN WAS PLACED, WHICH STABILIZED THE PATIENT'S BLOOD PRESSURE. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT THEN BECAME HYPOTENSIVE AND AN EPINEPHRINE BOLUS WAS ADMINISTERED. AN ECHOCARDIOGRAM REVEALED AN EFFUSION WITH NO LEFT VENTRICULAR MOVEMENT. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451521 AGILIS NXT INTRODUCER, 8.5F, LARGE CURL, 82CM INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, INC (AF-MINNETONKA) G408332 4203671

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R SWARTZ BRAIDED TRANSSEPTAL INTRODUCER:| INQUIRY AFOCUS II EP CATHETER: 87008/4435466| PN-004075/30945| PN-004075/30938| TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER:| THERAPY COOL FLEX ABLATION CATHETER:| A088017/4422488| BRK TRANSSEPTAL NEEDLE: 407200/4453239| 407356/4567292| CARDIAC ABLATION GENERATOR CONNECTING CABLE:| 85809, LOT UNK| INQUIRY AFOCUS II EP CATHETER: 87008/4480244| TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER:| ENSITE VELOCITY MAPPING SYSTEM| NON-SJM SCREW IN BIPOLAR PACING CATHETER:| MODEL UNK, LOT UNK