BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT TACTICATH

    MDR report key: 18374836 · Received December 20, 2023

    Report

    Report Number
    MW5149443
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    December 6, 2023
    Report Date
    December 18, 2023
    Manufacturer
    ABBOTT ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CATH TACTICATH SE BIDIRECT DF (LOT# 9213286) NOTED WITH DEFECT FOLLOWING TROUBLESHOOTING NEAR END OF A-FIB ABLATION PROCEDURE. MD NOTED CATH TIP DEFECT/MISSING PIECE UPON INSPECTION OF DEVICE FOLLOWING REMOVAL FROM PATIENT'S BODY. PACKAGING INSPECTED WITH NO INDICATION OF DAMAGE. PT ASSESSMENT FOLLOWING PROCEDURE CONSISTENT WITH BASELINE. CONCERN OF MISSING PIECE LEFT IN PTS BODY PER MD. CT SCAN ORDERED BY MD TO ASSESS FOR POSSIBLE LOCATION/RETAINMENT. CATH LAB UNIT MANAGER MADE AWARE AND EQUIPMENT/CATH RETAINED BY MANAGER FOR RISK REVIEW. PT TO BE ADMITTED FOLLOWING PROCEDURE FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297410 ABBOTT TACTICATH CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ABBOTT ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. 9213286

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female