BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 7004508 · Received November 6, 2017

    Report

    Report Number
    3002648230-2017-00596
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 17, 2017
    Report Date
    December 19, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED AT LEAST NINETEEN APPLICATIONS WERE PERFORMED WITH CATHETER 2AF283/05456-15 WITHOUT ANY ISSUE ON THE DATE OF THE EVENT. UPON VISUAL INSPECTION OF THE SHEATH 4FC12 / 99926-80, RESULTS SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. AIR ASPIRATION WAS REPRODUCED WHEN A TEST CATHETER WAS INTRODUCED THROUGH THE SHEATH IN THE STRAIGHT CONDITION. FUNCTIONAL TESTING OF THE SHEATH CONFIRMED THE HEMOSTATIC VALVE WAS LEAKING. AIR BUBBLES WERE OBSERVED THROUGH THE VALVE. IT WAS SUSPECTED THAT THE VALVE DISK WAS TORN. IN CONCLUSION, THE REPORTED ISSUE AIR INGRESS DURING ASPIRATION HAS BEEN CONFIRMED THROUGH TESTING BUT NOT CONFIRMED THROUGH THE DATA ANALYSIS. THE SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO A LEAKING HEMOSTATIC VALVE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR BUBBLES WERE OBSERVED WHEN ATTEMPTING TO ASPIRATE. THE SHEATH WAS REPLACED WITH RESOLVE, AND THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783385 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 99926

    Patients

    Seq Age Sex Outcome Treatment
    1