BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY ABLATION CATHETER-UNKNOWN

    MDR report key: 5913953 · Received August 30, 2016

    Report

    Report Number
    3005334138-2016-00045
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    December 1, 2015
    Report Date
    February 15, 2018
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE RIGHT CORONARY ARTERY OCCLUSION REMAINS UNKNOWN. PER THE IFU, MYOCARDIAL INFARCTION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS TRANSLATED FROM A PUBLISHED ARTICLE IN THE JOURNAL OF JAPAN ASSOCIATION FOR CLINICAL ENGINEERS. "THIS WAS THE CASE FOR (B)(6) MALE; THE RF CATHETER ABLATION (RFCA) WAS PROVIDED FOR PAROXYSMAL ATRIAL FIBRILLATION IN (B)(6) 2015. WITH ENSITE VELOCITY, THE PATIENT DEVELOPED ATRIAL FLUTTER DURING INFERIOR PULMONARY VEIN ISOLATION WHICH THE FLEXIBILITY IRRIGATION CATHETER, WHICH WAS USED TO PERFORM ABLATION ON THE CAVO TRICUSPID ISTHMUS (CTI) FOR BLOCK LINE. DURING CTI ABLATION, THE ATRIAL FLUTTER WAS STOPPED. THEN, THE CTI ABLATION WAS COMPLETED AND THE PROCEDURE WAS COMPLETED. THE PATIENT BP WAS 142/108 AND SPO2 WAS 98%. NO UNSTABLE ECG WAS NOTED AT THE TIME OF PROCEDURE COMPLETION. THE PATIENT WAS TRANSFERRED BACK TO THE WARD AND THE ECG MONITOR IN THE WARD REVEALED THE VENTRICULAR FIBRILLATION. THE DC AT 150J WAS PROVIDED TO BRING BACK THE SINUS RHYTHM. YET, LEAD II, LEAD III, LEAD AVF AND THE LEADS V4, V5, V6 REVEALED ST DROP. THE ECHOCARDIOGRAM REVEALED HYPOKINESIS AT THE LOWER WALL OF THE HEART. THE PHYSICIAN SUSPECTED THE RIGHT CORONARY ARTERY ANOMALY FOR ACUTE CORONARY SYNDROME (ACS). THE CORONARY ANGIOGRAPHY REVEALED THE COMPLETE TOTAL CORONARY OCCLUSION ON RCA#4AV WHICH WAS PERFORMED PERCUTANEOUS CORONARY INTERVENTION (PCI). FIRST THE BLOOD CLOT SUCTION WAS PERFORMED AND IT WAS CONFIRMED FINE WHITE BLOOD CLOTS RATHER THAN RED BLOOD CLOTS. THEN, THE BALLOON WAS USED FOR PRESTENOTIC DILATATION AND THE OPTICAL FREQUENCY DOMAIN IMAGING (OFDI) WAS PERFORMED WHICH REVEALED THE CONSTRICTION VASCULAR LUMEN AND BLOOD CLOTS. SEVERAL DILATATIONS WITH THE BALLOON WERE PERFORMED, BUT EVENTUALLY THE STENT WAS PLACED SINCE IT COULD BRING AGAIN THE CONSTRICTION BLOOD VESSEL. ON THE REPORT, IT STATED THAT THERE WAS THE PART WHICH THE DISTANCE WAS LESS THAN 5MM BETWEEN THE RIGHT ATRIUM AND ENDOCARDIUM SIDE. AS THE ABLATION SITE WAS CONSIDERED AS APPROXIMATELY 5MM IN SIZE, THE IRRIGATION CATHETER SHALL BE USED WITH GREAT CARE. IN THIS CASE, CORONARY ARTERY CT REVEALED #4AV WAS BRANCHED NEARBY #3 AND IT WAS RUNNING MORE CLOSE TO POSTERIOR WALL AND ENDOCARDIUM SIDE THAN NORMAL. DUE TO THAT, THE DISTANCE WAS MORE CLOSE TO CIT; SO, CTI ABLATION COULD BRING THE RIGHT CORONARY ARTERY OCCLUSION THOUGH IT REMAINED UNKNOWN THE CAUSE OF THE CORONARY ARTERY OCCLUSION." (2016 NO.57).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565378 FLEXABILITY ABLATION CATHETER-UNKNOWN CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention