BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6155265 · Received December 8, 2016

    Report

    Report Number
    3002648230-2016-00513
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 30, 2016
    Report Date
    February 16, 2017
    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 4FC12 / 08250-020 RESULT SHOWED THE FLEXCATH SHAFT WAS INTACT WITH NO APPARENT ISSUES. AIR ASPIRATION WAS REPRODUCED WHEN A CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED THE HEMOSTATIC VALVE WAS LEAKING AND THE VALVE WAS TORN. IN CONCLUSION, THE REPORTED ¿AIR BUBBLE¿ ISSUE CONFIRMED THROUGH TESTING. THE FLEXCATH SHEATH FAILED THE INSPECTION DUE TO TORN HEMO STATIC VALVE.

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: CLINICAL DATA FILES WERE ANALYZED ON 21 DECEMBER, 2016. THE REPORTED ISSUE OF AIR INGRESS DURING FLUSH AND ASPIRATION CANNOT BE CONFIRMED THROUGH DATA ANALYSIS. ANALYSIS OF THE RETURNED PRODUCT IS PENDING. 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, THE PHYSICIAN OBSERVED A LOT OF AIR BUBBLES DURING THE FLUSH AND ASPIRATION. THE SHEATH WAS REPLACED. 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
    805350 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 08250

    Patients

    Seq Age Sex Outcome Treatment
    1