BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F

    MDR report key: 11036738 · Received December 18, 2020

    Report

    Report Number
    3005334138-2020-00610
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 28, 2020
    Manufacturer
    ST. JUDE MEDICAL (AFD-PLYMOUTH)
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, NO ENSITE CASE STUDY WAS 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 TRANSIENT ISCHEMIC ATTACK 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.

    Description of Event or Problem · 1

    RELATED MFR NUMBERS: 2030404-2020-00105; 3005334138-2020-00611. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH NO ISSUES, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC DURING RECOVERY. THE PATIENT RETURNED TO STABLE CONDITION WITH NO LASTING SYMPTOMS OBSERVED. NO INFORMATION WAS AVAILABLE ON THE CAUSE OF THE TRANSIENT ISCHEMIC ATTACK. THERE WERE NO PERFORMANCE ALLEGATIONS AGAINST ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502314 TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL (AFD-PLYMOUTH) A-TCSE-DF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 1110-6-25-L CATHETER| ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿| 1110-6-25-L CATHETER| ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿