BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2193539 · Received August 5, 2011

    Report

    Report Number
    3002648230-2011-00119
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 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 IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED IN (B)(6). DURING THE LEFT SIDED ABLATIONS, THERE WAS MODERATE ST SEGMENT ELEVATION SEEN OF THE SURFACE ECG. THIS WAS OBSERVED AND RESOLVED WITHOUT INCIDENT WITHIN 5 MINUTES. THE LINES WERE CHECKED FOR AIR AND NONE WAS FOUND. THE CASE CONTINUED WITHOUT FURTHER ECG CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 26374

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability