BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH? QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM

    MDR report key: 4668673 · Received April 8, 2015

    Report

    Report Number
    3005334138-2015-00027
    Event Type
    Injury
    Date Received
    April 8, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 12, 2015
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE LOG FILES REVEALED THE DEVICE FUNCTIONED AS INTENDED AND THERE WERE NO CONTRIBUTING ANOMALIES. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION WAS UNABLE TO BE CONFIRMED AND REMAINS UNKNOWN. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK WITH THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING AN RE-DO ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER OBTAINING ACCESS TO THE LEFT ATRIUM THROUGH A PFO, A TACTICATH QUARTZ ABLATION CATHETER WAS USED TO ABLATE COMPLEX FRACTIONATED ELECTROGRAMS (CFES). DURING INITIAL ABLATION, THE PATIENT WENT INTO A TACHYCARDIA. CFE ABLATIONS WERE COMPLETED AND THE TACTICATH WAS WITHDRAWN BACK ACROSS THE PFO INTO THE RIGHT ATRIUM. THE PATIENT EXPRESSED DISCOMFORT AND THEN FELT FAINT AND WAS WITHOUT A BLOOD PRESSURE. A TRANS-ESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED REVEALING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT AND THE PROCEDURE CONTINUED WITH THE PATIENT REMAINING STABLE. THERE WERE NO PERFORMANCE ISSUES NOTED WITH ANY SJM DEVICE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233323 TACTICATH? QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM CARDIAC ABLATION PERCUTANEOUS CATHETER OAE ST. JUDE MEDICAL PN-004 075 4652623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AGILIS NXT INTRODUCER| FASTCATH INTRODUCER| INQUIRY OPTIMA CATHETER