BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, EL

    MDR report key: 17160048 · Received June 19, 2023

    Report

    Report Number
    3008452825-2023-00263
    Event Type
    Death
    Date Received
    June 19, 2023
    Date of Event
    May 26, 2023
    Report Date
    August 11, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    UDI-DI
    05414734200554
    PMA / PMN Number
    K894500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. A TRANSSEPTAL PUNCTURE WAS PERFORMED, BUT NO EFFUSION WAS SEEN ON ECHOGRAPHY DURING OR AFTER THE TRANSSEPTAL PUNCTURE. DURING RF LESIONS ON THE SEPTUM/ANTERIOR LEFT VENTRICLE, THE PATIENT WAS STABLE. THE PATIENT BECAME HYPOTENSIVE AT THE END OF THE PROCEDURE, WHEN CATHETERS WERE REMOVED FROM THE RIGHT VENTRICLE. AN ECHOGRAPHY REVEALED A PERICARDIAL EFFUSION AT THE RIGHT VENTRICULAR APEX AND AROUND 880 ML OF BLOOD WAS DRAINED FROM THE PERICARDIUM WITHOUT BLOOD RE-INJECTION. THE PROCEDURE WAS THEN COMPLETED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. IT IS ALLEGED THAT THE EFFUSION WAS DUE TO THE RESPONSE ELECTROPHYSIOLOGY QUADRIPOLAR CATHETER IN THE RIGHT VENTRICLE BECAUSE THE PATIENT BECAME HYPOTENSIVE WHEN THE CATHETER WAS REMOVED AND BECAUSE THE COLOR OF THE BLOOD REMOVED WITH THE DRAINAGE WAS BLOOD POOR IN OXYGEN. THE PROCEDURE WAS COMPLETED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. IT WAS NOTED THAT THE PATIENT DIED 1-2 DAYS AFTER THIS PROCEDURE DUE TO HEART FAILURE, SPECIFICALLY VENTRICULAR FIBRILLATION. THE PHYSICIAN STATED THAT THE PATIENT WAS FRAGILE BEFORE THE PROCEDURE AND HAD A LOW LVEF AROUND 30%. AN AUTOPSY CONFIRMED THAT THE PATIENT EXPIRED BECAUSE OF VF, AND THE DEATH DID NOT OCCUR BECAUSE OF THE CARDIAC PERFORATION. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE AUTOPSY RESULTS.

    Description of Event or Problem · 0

    DURING AN VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. A TRANSSEPTAL PUNCTURE WAS PERFORMED, BUT NO EFFUSION WAS SEEN ON ECHOGRAPHY DURING OR AFTER THE TRANSSEPTAL PUNCTURE. DURING RF LESIONS ON THE SEPTUM/ANTERIOR LEFT VENTRICLE, THE PATIENT WAS STABLE. THE PATIENT BECAME HYPOTENSIVE AT THE END OF THE PROCEDURE, WHEN CATHETERS WERE REMOVED FROM THE RIGHT VENTRICLE. AN ECHOGRAPHY REVEALED A PERICARDIAL EFFUSION AND AROUND 880 ML OF BLOOD WAS DRAINED FROM THE PERICARDIUM WITHOUT BLOOD RE-INJECTION. THE PROCEDURE WAS THEN COMPLETED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. IT IS ALLEGED THAT THE EFFUSION WAS DUE TO THE CATHETER IN THE RIGHT VENTRICLE BECAUSE THE PATIENT BECAME HYPOTENSIVE WHEN THE CATHETER WAS REMOVED AND BECAUSE THE COLOR OF THE BLOOD REMOVED WITH THE DRAINAGE WAS BLOOD POOR IN OXYGEN. THE PATIENT DIED AFTER THIS PROCEDURE DUE TO HEART FAILURE, SPECIFICALLY VENTRICULAR FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709537 RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, EL ELECTRODE RECORDING CATHETER DRF ST. JUDE MEDICAL 401226 8718862 05414734200554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D| O