BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 13584347 · Received February 22, 2022

    Report

    Report Number
    MW5107624
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 8, 2022
    Report Date
    February 17, 2022
    Manufacturer
    EDWARD LIFESCIENCES LLC.
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THROMBECTOMY PROCEDURE OF PATIENT'S LEFT FEMORAL/ILIAC, THE FOGARTY THROMBECTOMY BALLOON WAS INFLATED TO PULL THROMBUS BACK. WHEN THE FOGARTY CATHETER WAS INSPECTED OUTSIDE OF THE ARTERY, THE BALLOON PART OF THE CATHETER WAS DAMAGED AND PART OF THE BALLOON WAS MISSING. SURGEON ATTEMPTED TO RETRIEVE ANY REMAINING BALLOON FRAGMENTS. THE FRAGMENTS DO NOT SHOW UP ON XRAY. THE FLOW OF THE ARTERY DID NOT APPEAR DIFFERENT FROM PRIOR TO FOGARTY CATHETER TO AFTER THE CATHETER REMOVED (AFTER BALLOON ISSUE DISCOVERED). PATIENT DID NOT HAVE ANY KNOWN INJURY/ADVERSE EFFECT RELATED TO THE EVENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672913 FOGARTY ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARD LIFESCIENCES LLC. 63611725

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male