BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 7034004 · Received November 15, 2017

    Report

    Report Number
    3002648230-2017-00613
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED AT LEAST FIVE APPLICATIONS WERE PERFORMED WITH CATHETER 2AF284 / 79030-36 ON THE DATE OF THE EVENT WITH NO SYSTEM NOTICE. VISUAL INSPECTION OF FLEXCATH 4FC12 / 43590-052 SHOWED THE DEVICE WAS NOT INTACT AND WAS KINKED ON THE 2.3435 INCHES FROM THE TIP OF THE SHEATH. THE SHEATH FAILED THE TEST DUE TO THE KINK 2.3435 INCHES FROM THE TIP OF THE SHEATH. IN CONCLUSION, THE REPORTED SHEATH KINK ISSUE HAS BEEN CONFIRMED THROUGH TESTING BUT NOT CONFIRMED THROUGH THE DATA ANALYSIS. THE SHEATH FAILED THE INSPECTION DUE TO A KINK. 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 CRYO ABLATION PROCEDURE, THE DEFLECTION KNOB OF THE SHEATH WAS BROKEN. ADDITIONALLY, THE SHEATH WAS TWISTED ON FLUOROSCOPY. THE SHEATH WAS REPLACED AND 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
    812921 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 43590

    Patients

    Seq Age Sex Outcome Treatment
    1