BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 5101117 · Received September 24, 2015

    Report

    Report Number
    3002648230-2015-00316
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 27, 2015
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE, FLEXCATH ADVANCE 4FC12 WITH LOT NUMBER 30201-06, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE SHEATH SHOWED THAT THE DEVICE 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 WAS CONFIRMED THROUGH TESTING. THE SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO A LEAKING HEMOSTATIC VALVE.

    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 AT THE END OF A CRYO ABLATION PROCEDURE, WHILE THE BALLOON CATHETER WAS BEING EXTRACTED FROM THE SHEATH BLOOD LEAKAGE WAS OBSERVED FROM THE VALVE OF THE SHEATH. 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
    631954 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 30201

    Patients

    Seq Age Sex Outcome Treatment
    1