BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2222677 · Received August 25, 2011

    Report

    Report Number
    3002648230-2011-00142
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY ONE FLEXCATH STEERABLE SHEATH (LOT 61556, SERIAL NUMBER (B)(4)) WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED ISSUE WAS CONFIRMED THROUGH TESTING. DISSECTION SHOWED A LEAKING HEMOSTATIC VALVE. THE SECOND FLEXCATH STEERABLE SHEATH (LOT 61556, UNKNOWN SERIAL NUMBER) WAS DISCARDED BY THE HOSPITAL AFTER THE PROCEDURE AND WAS NOT RETURNED FOR EVALUATION. A FIELD ACTION WAS INITIATED IN JULY 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THIS POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS.

    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 R EPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING ASPIRATION, AIR WAS SEEN IN THE SIDEPORT OF FLEXCATH STEERABLE SHEATH LOT 61556 SERIAL NUMBER (B)(4). THE SHEATH WAS REPLACED BY ANOTHER FLEXCATH STEERABLE SHEATH OF THE SAME LOT (SERIAL NUMBER IS UNKNOWN). AGAIN, AIR WAS SEEN IN THE SIDEPORT DURING ASPIRATION. SOME BLOOD WAS LEAKING OUT OF THE VALVE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 61556

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR