BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVEWIRE¿ TC ABLATION CATHETER

    MDR report key: 18248184 · Received December 1, 2023

    Report

    Report Number
    2182269-2023-00055
    Event Type
    Injury
    Date Received
    December 1, 2023
    Report Date
    January 9, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LPB
    PMA / PMN Number
    P960016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G1, G3, H2, H3, H6 THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN HERZSCHRITTMACHERTHERAPIE & ELEKTROPHYSIOLOGIE (NOV 10, 2023) "ZERO-FLUORO ATRIOVENTRICULAR-NODAL REENTRANT TACHYCARDIA ABLATION"; SOETHER, CHRISTINA THE AUTHORS RETROSPECTIVELY ANALYZED 68 PATIENTS THAT UNDERWENT AVNRT-RFCA. ONE GROUP WAS A PRIORI ALLOCATED TO CONVENTIONAL FLUOROSCOPY MAPPING. IN 38 CASES, THE ELECTROPHYSIOLOGIST CHOSE TO USE 3D-EAM FOR ABLATION. OF THESE PATIENTS, 20 COULD BE ABLATED WITHOUT FLUOROSCOPY USE (ZEROFLUORO). IN 18 CASES THAT WERE INITIALLY INTENDED AS 3D-EAM, ADDITIONAL FLUOROSCOPY USE WAS NECESSARY DUE TO DIFFICULT ANATOMIC CONDITIONS (CONVERTEDFLUORO). PROCEDURE DURATION, FLUOROSCOPY DURATION AND DOSE, AS WELL AS COMPLICATIONS WERE ANALYZED. PROCEDURE DURATION WAS SIMILAR FOR THE CONVFLUORO AND ZEROFLUORO GROUPS. THE CONVERTEDFLUORO GROUP SHOWED LONGER PROCEDURE DURATION COMPARED TO THE CONVFLUORO GROUP. THE USE OF 3D-EAM SIGNIFICANTLY REDUCED FLUOROSCOPY DURATION COMPARING THE CONVFLUORO WITH THE CONVERTEDFLUORO GROUP. THE DIFFERENCE IN FLUOROSCOPY DOSE BETWEEN CONVFLUORO AND CONVERTED FLUORO DID NOT REACH SIGNIFICANCE. IN ZEROFLUORO CASES, NO RADIATION WAS USED AT ALL. 3D-EAM-GUIDED RFCA WAS PRIMARILY SUCCESSFUL IN ALL PATIENTS. OVERALL, THERE WERE ONLY FEW MINOR COMPLICATIONS IN THE DIFFERENT GROUPS. NO MAJOR COMPLICATIONS OCCURRED. ONE TRANSIENT RIGHT BUNDLE BRANCH BLOCK (RBBB), FOUR TRANSIENT ATRIOVENTRICULAR (AV) BLOCK III AND ONE AV BLOCK II OCCURRED WITH FULL RECOVERY EACH. NO MAJOR (PERSISTENT) COMPLICATIONS OCCURRED IN ANY GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429865 LIVEWIRE¿ TC ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening