BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY OCCLUSION CATHETER

    MDR report key: 3120868 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20130
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    MJN
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED WITHOUT ANY ATTACHED COMPONENTS. THE EVALUATION INCLUDED VISUAL EXAMINATION AND NOTATION OF ANY ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE BALLOON AND BALLOON WINDINGS WERE VISUALLY INSPECTED FOR INDICATION OF DAMAGE OR ABNORMALITY AND THE BALLOON WAS FOUND TO HAVE A RUPTURED AREA, 0.46" X 0.32¿ (OR 1.1 CM X 0.9 CM) IN SIZE, AROUND THE DISTAL PORTION OF THE BALLOON. THERE WAS NO DAMAGE FOUND ON THE WINDINGS. THE RUPTURED EDGES OF THE BALLOON COULD NOT BE MATCHED UP, INDICATING THERE WAS LATEX MATERIAL. BLOOD WAS OBSERVED IN THE SPRING TIP. THERE WAS NO DAMAGE TO THE CATHETER BODY. VISUAL EXAMINATIONS WERE PERFORMED AT 10X MAGNIFICATION AND WITH THE UNAIDED EYE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE COMPLAINT WAS CONFIRMED BUT THE DIFFICULTY REPORTED APPEARS TO BE RELATED PATIENT AND PROCEDURAL FACTORS. AS PER THE PRODUCT IFU, EXPOSURE TO CALCIFIED PLAQUE WITHIN THE VESSEL MAY INCREASE THE POSSIBILITY OF BALLOON RUPTURE. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED ON THE RETURNED PRODUCT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED DURING AN ANEURYSM OPERATION. AS REPORTED, THE CATHETER MAY HAVE BEEN USED IN A CALCIFIED AREA AND THAT COULD HAVE BEEN THE CAUSE OF THE PROBLEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222076 FOGARTY OCCLUSION CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EDWARDS LIFESCIENCES, PR 62080822F

    Patients

    Seq Age Sex Outcome Treatment
    1