BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 3253269 · Received July 29, 2013

    Report

    Report Number
    2015691-2013-20701
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED WITHOUT A SYRINGE OR THE PACKAGE. EXAMINATION OF THE CATHETER BODY AND THE BALLOON AND WINDINGS WAS PERFORMED AT 10X MAGNIFICATION. THERE WAS NO VISIBLE DAMAGE OBSERVED. THE BALLOON WAS INFLATED WITH 0.2ML AND INFLATED CLEARLY AND CONCENTRICALLY AND LEAKAGE WAS NOT OBSERVED. FREE DEFLATION TIME (FREE IMPLIES UNAIDED IN AIR) WAS LESS THAN 1 SECOND AND IS WITHIN THE ALLOWABLE SPECIFICATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE COMPLAINT OF BALLOON DEFLATION WAS NOT CONFIRMED. AS SUGGESTED IN THE PRODUCT IFU, THE MAXIMUM GAS CAPACITY FOR BALLOON INFLATION IS 0.2ML. HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE BALLOON DOES NOT DEFLATE WHEN INFLATION IS TESTED BEFORE USE. NO PROBLEM OF DEFLATING THE BALLOON AFTER VERIFICATION, WHICH MEANS THE BALLOON DEFLATION PROBLEM WAS RESOLVED AFTER THE FIRST TESTING FAILED. THE SECOND/THIRD/FOLLOWING TIMES BALLOON COULD BE DEFLATED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353874 FOGARTY ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES, PR 12A0602F 59426801

    Patients

    Seq Age Sex Outcome Treatment
    1