BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL PATH 7F, 1304-CP-7-25-L-AB (USA)

    MDR report key: 2202638 · Received August 8, 2011

    Report

    Report Number
    2030404-2011-00231
    Event Type
    Death
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE COOL PATH 7F CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALIES. FUNCTIONAL TESTING OF THE DEVICE CONFIRMED THE CATHETER PASSED CONTINUITY, RESISTANCE AND EKG TESTING. THE CATHETER CREATED A CURVE WHEN DEFLECTED THAT MET THE TEMPLATE REQUIREMENT. STEERING FORCE TO CREATE A CURVE WAS WITHIN SPECIFICATION CRITERIA. THE CATHETER ALSO SUCCESSFULLY PASSED THE FLOW RATE, PRESSURE DROP AND ABLATION SIMULATION TEST. MICROSCOPIC EVALUATION OF THE TIP OF THE CATHETER REVEALED NO ANOMALIES. THE THERMAL SYSTEM OF THE DEVICE WAS VERIFIED WITH NO ISSUES NOTED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION, ST ELEVATION AND SUBSEQUENTLY EXPIRED. FOLLOWING THE BASELINE ELECTROPHYSIOLOGY STUDY THE PHYSICIAN NOTED OCCASIONAL LEFT SIDED PRE VENTRICULAR CONTRACTIONS (PVC'S). PER HOSPITAL PROTOCOL, ISUPREL WAS INITIATED TO INCREASE THE NUMBER OF PVC'S. THE PHYSICIAN ADVANCED THE THERAPY COOL PATH CATHETER INTO THE LEFT VENTRICLE AND PERFORMED ACTIVATION MAPPING WITH THE EN SITE SYSTEM. FOLLOWING APPROXIMATELY THREE TWO MINUTE ABLATIONS THAT PVC'S WERE NO LONGER PRESENT AND THE PROCEDURE WAS STOPPED TO ASSESS PATIENT RHYTHM. RHYTHM ASSESSMENT CONCLUDED THE PRESENCE OF RIGHT SIDED PVC'S AND RARE LEFT SIDED PVC'S. THE PHYSICIAN INSTRUCTED THE ANESTHESIOLOGIST TO INCREASE THE ISUPREL AND IT WAS NOTED THE PATIENT'S RHYTHM CHANGED TO RAPID VENTRICULAR FIBRILLATION. THE PATIENT WAS DEFIBRILLATED WHICH RESTORED SINUS RHYTHM. THE ISUPREL INFUSION WAS CONTINUED AND THE PATIENT HAD TWO MORE EPISODES OF VENTRICULAR FIBRILLATION, BOTH SUCCESSFULLY CARDIOVERTED TO SINUS RHYTHM. SIGNIFICANT ST ELEVATION WAS OBSERVED ON A 12 LEAD EGG. THE EP CATHETERS WERE REMOVED FROM THE PATIENT AND A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED REVEALING DIMINISHED VENTRICULAR FUNCTION BUT NO PERICARDIAL EFFUSION. THE PATIENT'S CARE WAS THEN ASSUMED BY THE CATH LAB TEAM. FOLLOW UP OF THE PATIENT REVEALED, THE PATIENT HAD TWO OCCLUDED CORONARY ARTERIES AND THE PATIENT EXPIRED IN THE ICU AT 7:15 PM THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-L-AB (USA) CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 84309 3348579

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death ENSITE SYSTEM