BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6818486 · Received August 24, 2017

    Report

    Report Number
    3002648230-2017-00461
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 25, 2017
    Report Date
    July 28, 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

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED AT LEAST SIX INJECTIONS WERE PERFORMED WITH CATHETER 2AF284 / 12130-81 ON THE DATE OF THE EVENT WITHOUT ANY SYSTEM NOTICE. FAILURE FILE DID NOT SHOW ANY SYSTEM NOTICE TRIGGERED ON THE DATE OF THE EVENT. UPON VISUAL INSPECTION OF THE FLEXCATH SHEATH 4FC12 / 70121-055, RESULTS SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. AIR ASPIRATION WAS REPRODUCED WHEN A LAB TEST CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED THE HEMOSTATIC VALVE WAS LEAKING. IN CONCLUSION, THE REPORTED AIR INGRESS ISSUE WAS CONFIRMED THROUGH TESTING BUT NOT CONFIRMED THROUGH THE DATA ANALYSIS. THE CATHETER PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION. THE SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO A LEAKING HEMOSTATIC VALVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER WAS INFLATED OUTSIDE OF THE PATIENT¿S BODY AND AIR WAS A SPIRATED. WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, AIR WAS INTRODUCED AND ¿MORE RESISTANCE THAN USUAL¿ WAS OBSERVED. IT WAS NOTED THAT NEITHER THE BALLOON CATHETER NOR THE SHEATH WERE 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
    598488 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 70121

    Patients

    Seq Age Sex Outcome Treatment
    1