BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6035282 · Received October 17, 2016

    Report

    Report Number
    3002648230-2016-00439
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 21, 2016
    Report Date
    November 25, 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

    EVENT SUMMARY: UPON VISUAL INSPECTION OF FLEXCATH SHEATH 4FC12 / 09419-92, RESULTS SHOW THE STOPCOCK WAS INTACT WITH NO APPARENT ISSUES. AIR ASPIRATION WAS REPRODUCED WHEN A TEST ARCTIC FRONT CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED THE HEMOSTATIC VALVE WAS LEAKING AND THE VALVE WAS TORN. IN CONCLUSION, THE REPORTED ISSUE (VALVE WAS LEAKY) WAS CONFIRMED THROUGH TESTING. THE FLEXCATH SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO A LEAKING HEMOSTATIC VALVE. 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, BEFORE INSERTION INTO THE PATIENT, THE SHEATH WAS ASPIRATED AND AFTER INSERTION OF THE BALLOON CATHETER, THE VALVE WAS LEAKY. THE SHEATH WAS REPLACED WITH ONE OF THE SAME LOT. THE CASE WAS (B)(4). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684780 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 09419

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 09419, SHEATH