BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2202621 · Received August 11, 2011

    Report

    Report Number
    3002648230-2011-00128
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    October 7, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND PASSED THE INSPECTION AS PER SPECIFICATION. THE VISUAL INSPECTION SHOWED THAT THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. MANY ASPIRATION / INJECTIONS WERE PERFORMED WITHOUT HAVING AIR BUBBLES OR LEAKING THROUGH THE HEMOSTATIC VALVE. THE DEFLECTION FUNCTIONALITY WORKED AS PER SPECIFICATION.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE IN (B)(6), IT WAS NOTED THAT THE PATIENT HAD ELEVATED ST SEGMENTS IN THE INFERIOR LEADS OF THE ECG. THE ECG RETURNED TO NORMAL UNDER THREE MINUTES AND THE PATIENT RECOVERED FROM THE PROCEDURE WITH NO INJURY. THE VACUUM WAS NOT ENABLED PRIOR TO THE ARCTIC FRONT REINTRODUCTION DUE TO AN OVERSIGHT BUT THE FLEXCATH STEERABLE SHEATH WAS PROPERLY FLUSHED.

    Description of Event or Problem · 1

    AFTER AN INITIAL ROUND OF ABLATIONS WERE PERFORMED, THE ARCTIC FRONT CATHETER WAS REMOVED, VEIN ISOLATION WAS CHECKED, AND THE ARCTIC FRONT CATHETER WAS RE-INSERTED INTO THE FLEXCATH SHEATH TO PERFORM FURTHER ABLATIONS. THE VACUUM WAS NOT ENABLED PRIOR TO THE ARCTIC FRONT REINTRODUCTION DUE TO AN OVERSIGHT BUT THE FLEXCATH STEERABLE SHEATH WAS PROPERLY FLUSHED. DURING BALLOON MANIPULATION AND OCCLUSION ATTEMPTS FOR THE FIRST ABLATION AFTER THE REINTRODUCTION, IT WAS NOTICED THAT THE PATIENT HAD ST SEGMENT ECG CHANGES IN THE INFERIOR LEADS. ATRIAL PACING AT 100BPM WS COMMENCED AND THE OXYGEN LEVELS WERE INCREASED TO 100%. THE ECG CHANGES RESOLVED IN JUST UNDER THREE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 97317

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (B)(4)