BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2181670 · Received July 27, 2011

    Report

    Report Number
    3002648230-2011-00095
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED ISSUE WAS CONFIRMED THROUGH TESTING. DISSECTION SHOWED A LEAKING HEMOSTATIC VALVE. A FIELD ACTION WAS INITIATED IN (B)(4) 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THIS POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS.

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE IN (B)(6), AT THE START OF THE FIRST APPLICATION, THE PHYSICIAN SAW AIR IN THE LAA ON FLUOROSCOPY. THE APPLICATION WAS STOPPED AND A TEE WAS DONE. THE TEE CONFIRMED THAT THERE WAS A SMALL AIR BUBBLE IN THE LAA. THE PHYSICIAN SUCTIONED THE AIR BUBBLE WITH A MULTIPURPOSE CATHETER. THE AIR BUBBLE WAS REMOVED AND THE PROCEDURE WAS STOPPED. THERE WERE NO CLINICAL COMPLICATIONS. THE PATIENT STAYED ONE NIGHT IN THE HOSPITAL AND WAS DISCHARGED THE NEXT DAY. THE PATIENT WAS IN GOOD HEALTH AND DID NOT HAVE ANY PHYSIOLOGICAL OR NEUROLOGICAL COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 26378

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR