BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2223533 · Received August 25, 2011

    Report

    Report Number
    3002648230-2011-00146
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    September 22, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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 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 JULY 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THIS POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS. THIS DEVICE FAILURE CAUSED THE REPORTED AIR INGRESS DURING ASPIRATION, BUT IS NOT CONSIDERED TO BE RELATED TO THE PERICARDIAL EFFUSION THAT WAS OBSERVED IN THE PATIENT AT THE END OF THE CASE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE, THERE WAS AIR PRESENT IN THE FLEXCATH STEERABLE SHEATH DURING ASPIRATION. THE FLEXCATH SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED. A PERICARDIAL EFFUSION WAS NOTED AT THE END OF THE CASE. THERE WAS NO PERFORATION. THE PATIENT WAS KEPT UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 38075

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization ARCTIC FRONT CARDIAC CRYOABLATION CATHETER(2AF282)