BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER

    MDR report key: 12331114 · Received August 17, 2021

    Report

    Report Number
    9680001-2021-00052
    Event Type
    Injury
    Date Received
    August 17, 2021
    Report Date
    August 17, 2021
    Manufacturer
    VENUSA DE MEXICO S.A. DE C.V.
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: TACTICATH QUARTZ, ADVISOR HD GRID, EVENT DATE UNKNOWN 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 · 1

    RELATED MANUFACTURER REPORT NUMBERS: 9680001-2021-00051, 3005334138-2021-00476. THE FOLLOWING WAS PUBLISHED IN HEART RHYTHM TITLED, "CLOSE-COUPLED PACING TO IDENTIFY THE ¿FUNCTIONAL¿ SUBSTRATE OF VENTRICULAR TACHYCARDIA: LONG-TERM OUTCOMES OF THE PACED ELECTROGRAM FEATURE ANALYSIS TECHNIQUE" BY DEREK CRINION, MD, ET AL.: MAJOR ACUTE COMPLICATIONS OCCURRED IN 3 CASES: 1 STROKE, 1 RETROPERITONEAL BLEED, AND 1 POSTPROCEDURAL DEATH (DAY 5: DECOMPENSATED HEART FAILURE AND PEA ARREST). THIS CASE WAS EXCLUDED FROM LONG-TERM RECURRENCE DATA. THREE PATIENTS (7.5%) DIED DURING FOLLOW-UP. THEIR CLINICAL NOTES WERE REVIEWED, INCLUDING ICD INTERROGATIONS, TO RULE OUT RECURRENCE OF MONOMORPHIC VT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228984 TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE VENUSA DE MEXICO S.A. DE C.V. AFD0218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention