BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIEWFLEX¿ XTRA ICE CATHETER

    MDR report key: 8529852 · Received April 18, 2019

    Report

    Report Number
    3008452825-2019-00149
    Event Type
    Death
    Date Received
    April 18, 2019
    Date of Event
    March 29, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    OBJ
    UDI-DI
    05415067002082
    PMA / PMN Number
    K133853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF A CARDIAC ARREST AND PATIENT DEATH WAS REPORTED. 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.

    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 CARDIAC PERFORATION AND PATIENT DEATH COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION. FURTHER INFORMATION REGARDING TREATMENT, DATE OF PATIENT DEATH AND HOW THE ADVERSE EVENT WAS CONFIRMED WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    RELATED MFG NUMBERS: 3005334138-2019-00211, 2030404-2019-00023, 2030404-2019-00024, AND 2182269-2019-00045. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE THE PATIENT WENT INTO CARDIAC ARREST AND SUBSEQUENTLY PASSED AWAY. AFTER THE PROCEDURE WAS COMPLETED AND ALL THE SHEATHS, CATHETERS, AND INTRODUCERS WERE REMOVED, THE PATIENT WENT INTO CARDIAC ARREST AND EMERGENCY MEDICAL MEASURES WERE TAKEN. THE PATIENT SUBSEQUENTLY EXPIRED A FEW DAYS AFTER THE EVENT DUE TO UNKNOWN CAUSES. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321646 VIEWFLEX¿ XTRA ICE CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ ST. JUDE MEDICAL, COSTA RICA LTDA D087031 6744199 05415067002082

    Patients

    Seq Age Sex Outcome Treatment
    1 Death AGILIS STEERABLE INTRODUCER| INQUIRY OPTIMA CATHETER| INQUIRY STEERABLE CATHETER| TACTICATH ABLATION CATHETER