BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 12064354 · Received June 24, 2021

    Report

    Report Number
    3008452825-2021-00356
    Event Type
    Death
    Date Received
    June 24, 2021
    Date of Event
    June 18, 2021
    Report Date
    January 19, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    UDI-DI
    05415067020031
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B2, B5.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, NO LOG FILES WERE RECEIVED. 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 TAMPONADE REMAINS UNKNOWN. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT EXPIRED ON (B)(6) 2021, 4 MONTHS POST PROCEDURE.

    Description of Event or Problem · 1

    FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION. TWO HOURS POST PROCEDURE, THE PATIENT EXPERIENCED A HEMODYNAMIC INSTABILITY RELATED TO A CARDIAC TAMPONADE TREATED INITIALLY WITH PERICARDIOCENTESIS AND SUBSEQUENTLY WITH DRAINAGE AND SURGICAL CORRECTION OF THE BREACHES AT THE LEFT VENTRICLE APEX WITH STITCHES IN STERNOTOMY PROCEDURE. THE PATIENT IS STILL HOSPITALIZED IN INTENSIVE CARE UNIT, AN INTRA-AORTIC BALLOON PUMP (IABP) HAS BEEN IMPLANTED TO SUPPORT THE PATIENT HEMODYNAMICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960090 FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL A-FASE-D 7721260 05415067020031

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| D