BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 5841265 · Received August 2, 2016

    Report

    Report Number
    3002648230-2016-00304
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 7, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE SHEATH, 4FC12 WITH LOT NUMBER 81702-49, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE SHEATH SHOWED THE STOPCOCK WAS INTACT WITH NO APPARENT ISSUES. AIR ASPIRATION WAS REPRODUCED WHEN A TEST BALLOON CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED THE HEMOSTATIC VALVE WAS LEAKING; THE VALVE WAS TORN. IN CONCLUSION, THE REPORTED ISSUE OF AIR INGRESS WAS CONFIRMED THROUGH TESTING. THE SHEATH, 4FC12 WITH LOT NUMBER 81702-49, FAILED THE RETURNED PRODUCT INSPECTION DUE TO A LEAKING HEMOSTATIC VALVE.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 CRYOABLATION PROCEDURE, IT WAS NOT POSSIBLE TO ASPIRATE THE SHEATH WITHOUT AIR BUBBLES. THE SHEATHS WERE REPLACED AND THE PROCEDURE 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
    492706 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 81702

    Patients

    Seq Age Sex Outcome Treatment
    1