BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXABILITY ABLATION CATHETER, SENSOR ENABLED

    MDR report key: 8752459 · Received July 2, 2019

    Report

    Report Number
    3005334138-2019-00343
    Event Type
    Death
    Date Received
    July 2, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 27, 2020
    Manufacturer
    ST. JUDE MEDICAL (AFD-PLYMOUTH)
    Product Code
    OAD
    UDI-DI
    05415067020062
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D11, G4, H2.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED A PLEURAL EFFUSION OCCURRED WITH THE PATIENT ON (B)(6) 2020, HOWEVER NO FURTHER DETAILS REGARDING THE EFFUSION IS AVAILABLE AND IT IS UNKNOWN IF IT IS RELATED TO THE ORIGINALLY REPORTED ABLATION PROCEDURE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE: 2182269-2019-00093, 2182269-2019-00094, 3005334138-2019-00368, 2030404-2019-00054, 3005334138-2019-00369, 3005334138-2019-00370, 2182269-2019-00095. DURING AN VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. DURING LEFT BUNDLE RIGHT SUPERIOR AXIS WITH V2 TRANSITION, THE PATIENT BECAME HEMODYNAMIALLY UNSTABLE. PACEMAKING WAS TERMINATED AND ICE CONFIRMED A CIRCUMFERENTIAL PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE DRAIN WAS LEFT IN PLACE. PERCLOSE WAS ADMINISTERED. THE PATIENT WAS STABLE AND DISCHARGED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Additional Manufacturer Narrative · 1

    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 CARDIAC TAMPONADE COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE. FURTHER INFORMATION REGARDING THE EVENT WERE REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    FURTHER INFORMATION RECEIVED CONFIRMED THE PATIENT EXPIRED. THE PATIENT WAS ADMITTED FOR SEPSIS, ACUTE LEG PAIN AND ATP. THE PRINCIPLE DIAGNOSIS WAS CARDIOGENIC SHOCK, SEPTIC SHOCK AND DEMPYEMA. THE PATIENT BECAME HYPOTENSIVE AND HYPOXIC, AND LATER EXPIRED. THE CAUSE OF DEATH IS UNKNOWN, HOWEVER IT IS NOT ATTRIBUTED TO THE ABLATION PROCEDURE OR STUDY DEVICE.

    Description of Event or Problem · 1

    DURING AN ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549899 FLEXABILITY ABLATION CATHETER, SENSOR ENABLED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL (AFD-PLYMOUTH) A-FASE-DF 6538245 05415067020062

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| O ADVISOR¿ HD GRID MAPPING CATHETER, SE| AGILIS¿ INTRODUCER (X2)| LIVEWIRE¿ EP CATHETER DUO-DECAPOLAR| SWARTZ¿ BRAIDED INTRODUCER, LAMP| SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER| VIEWFLEX¿ XTRA ICE CATHETER