BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2841861 · Received November 21, 2012

    Report

    Report Number
    3002648230-2012-00112
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    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 WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE VISUAL INSPECTION SHOWED THAT THE SHAFT WAS KINKED AT 2.4 FROM THE TIP, WHICH DID NOT AFFECT THE PERFORMANCE OF THE SHEATH. THE FLEXCATH SHEATH PASSED THE PERFORMANCE TEST AS PER SPECIFICATION. SEVERAL ASPIRATION/INJECTIONS WERE PERFORMED WHILE A TEST CATHETER WAS ROTATED IN DIFFERENT DIRECTIONS. NO AIR BUBBLES OR LEAKING THROUGH THE VALVE WERE NOTICED. THE HEMOSTATIC VALVE WAS LEAK TIGHT. BIN FILES SHOWED NO PARTICULAR ISSUES DURING THE APPLICATION WHERE ST ELEVATION WAS OBSERVED. THE FLOW, PRESSURE AND TEMPERATURE ARE WITHIN SPECIFICATION AND HEPARINIZED SALINE WAS INJECTED DURING THE WHOLE INFLATION PERIOD (161 SECONDS).

    Description of Event or Problem · 1

    DURING THE SECOND CRYOABLATION IN THE (B)(6), ST ELEVATION WAS NOTICED IN THE INFERIOR ECG LEADS WHICH LASTED APPROXIMATELY 4 MINUTES. ONCE THE ST ELEVATION RESOLVED, THE CASE CONTINUED WITHOUT FURTHER INCIDENT. A MANUAL PRESSURE BAG WAS USED TO IRRIGATE THE SHEATH WITH HEPARINIZED SALINE DURING THE ENTIRE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1