BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 5630730 · Received May 4, 2016

    Report

    Report Number
    2015691-2016-01470
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 21, 2016
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE 120805F CATHETER WITHOUT THE PACKAGING FOR EXAMINATION. THE BALLOON WAS FOUND TO BE RUPTURED AROUND THE CIRCUMFERENCE. THERE IS NO DAMAGE TO THE BALLOON WINDINGS OR CATHETER BODY. EXAMINATION WAS UNABLE TO DETERMINE IF THE EDGES OF THE RUPTURED LATEX MATCH, AND IF LATEX IS MISSING. AS STATED IN THE IFU THE AMOUNT OF INFLATION MEDIA SHOULD BE CHECKED PRIOR TO EACH INFLATION OF THE BALLOON SO NOT TO EXCEED THE MAXIMUM INFLATION VOLUME. PER THE IFU THE RECOMMENDED INFLATION MEDIA IS 1.5ML LIQUID AND 3.0ML AIR. IFU WARNING - BALLOON RUPTURE AND CATHETER SEPARATION AS A RESULT OF EXCESSIVE PULL FORCE APPLIED TO REMOVE ADHERENT MATERIAL ARE THE MOST FREQUENT CAUSES OF REPORTED FAILURES. THE POSSIBILITY OF BALLOON RUPTURE MUST BE TAKEN INTO ACCOUNT WHEN CONSIDERING THE RISKS INVOLVED IN ANY EMBOLECTOMY PROCEDURE. TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AND PULL FORCE FOR EACH SIZE CATHETER. THE MAXIMUM PULL FORCE FOR THIS CATHETER IS 2.0 LBS. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BURST DURING A THROMBECTOMY PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286881 FOGARTY ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES PR 120805F 60274526

    Patients

    Seq Age Sex Outcome Treatment
    1