BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE

    MDR report key: 9744990 · Received February 24, 2020

    Report

    Report Number
    3008452825-2020-00113
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    February 4, 2020
    Report Date
    March 6, 2020
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DRF
    UDI-DI
    05414734201377
    PMA / PMN Number
    K002976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 5F, QUADRIPOLAR, JSN, SUPREME EP CATHETER WAS RECEIVED FOR EVALUATION. ELECTRODES 1-4 MET SPECIFICATIONS OF ACCEPTABLE RESISTANCE VALUES WITH NO OPEN OR SHORT CIRCUITS DETECTED. NO VISUAL ANOMALIES WERE NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED CARDIAC PERFORATION CANNOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE RESULTS, METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2020-00012, 3008452825-2020-00112, 2182269-2020-00020, 2182269-2020-00021, 2182269-2020-00022, 2030404-2020-00013, 3005334138-2020-00072. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT BECAME HYPOTENSIVE, SO AN ULTRASOUND WAS PERFORMED, CONFIRMING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210092 SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, COSTA RICA LTDA 401443 7268488 05414734201377

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention AGILIS INTRODUCER X2| BRK TRANSSEPTAL NEEDLE| INQUIRY AFOCUS CATHETER| LIVEWIRE CATHETER| TACTICATH SE CATHETER| VIEWFLEX ICE CATHETER| AGILIS INTRODUCER X2| BRK TRANSSEPTAL NEEDLE| INQUIRY AFOCUS CATHETER| LIVEWIRE CATHETER| TACTICATH SE CATHETER| VIEWFLEX ICE CATHETER