BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH? QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM

    MDR report key: 4308666 · Received December 9, 2014

    Report

    Report Number
    3005334138-2014-00003
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 12, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    PP130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED MANUFACTURER REFERENCE 3005188751-2014-00142. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING ATRIAL FIBRILLATION ABLATION PROCEDURE USING A TACTICATH QUARTZ ABLATION CATHETER WITH AN AGILIS NXT INTRODUCER, A PERICARDIAL EFFUSION OCCURRED. REPEATED APPLICATIONS OF RF ENERGY WERE PERFORMED IN ONE OF THE LEFT PULMONARY VEINS. THE PHYSICIAN NOTED THE CONTRACTION OF THE POSTERIOR LEFT VENTRICLE WAS SLIGHTLY DIMINISHED ON FLUOROSCOPY. FOLLOWING THE PROCEDURE, A DECREASE IN BLOOD PRESSURE WAS NOTED. AN ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION AND A CHEST X-RAY REVEALED A SLIGHTLY RAISED LEFT DIAPHRAGM. NO INTERVENTION WAS REQUIRED AND THE PATIENT WAS MONITORED IN THE HOSPITAL FOR 4-5 DAYS AND THEN DISCHARGED. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793569 TACTICATH? QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL PN-004 075

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization FAST-CATH SWARTZ TRANSSEPTAL INTRODUCER| BRK TRANSSEPTAL NEEDLE| SUPREME EP CATHETER| ENSITE VELOCITY CARDIAC MAPPING SYSTEM| INQUIRY AFOCUS II EP CATHETER| AGILIS NXT INTRODUCER