BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 5526424 · Received March 25, 2016

    Report

    Report Number
    3002648230-2016-00107
    Event Type
    Malfunction
    Date Received
    March 25, 2016
    Report Date
    May 30, 2016
    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: PATIENT DATA FILES WERE NOT RECEIVED FOR THIS CASE. UPON VISUAL INSPECTION OF FLEXCATH SHEATHS 4FC12 / 81715-33, 81715-66, AND 81715-68 SHOWED THE DEVICES WERE INTACT WITH NO APPARENT ISSUES. AIR ASPIRATION WAS REPRODUCED WHEN A TEST ARCTIC FRONT CATHETER WAS INTRODUCED THROUGH THE SHEATHS. DISSECTION SHOWED THE HEMOSTATIC VALVES WERE LEAKING; VALVES WERE TORN. IN CONCLUSION, THE REPORTED ISSUE HAS BEEN CONFIRMED THROUGH TESTING. THE FLEXCATH SHEATHS FAILED THE RETURNED PRODUCT INSPECTION DUE TO LEAKING HEMOSTATIC VALVE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER POSTAL CODE IS (B)(6). THE CODE WAS REMOVED TO FACILITATE TIMELY REGULATORY REPORT SUBMISSION, AND SOLELY AS A TEMPORARY WORKAROUND TO A VALIDATION ISSUE FOR SECTION.

    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 PRE-OP OF A CRYOABLATION PROCEDURE, THERE WAS A VALVE LEAK REGARDING THE SHEATH. THE SHEATH WAS REPLACED. THIS WAS NOT CASE RELATED, AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181544 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 81715

    Patients

    Seq Age Sex Outcome Treatment
    1