BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER

    MDR report key: 2964053 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19294
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SILICONE MATERIAL WAS CONFIRMED TO BE A MEDICAL GRADE COMPONENT. THE MANUFACTURING OPERATORS WERE MADE AWARE OF THE COMPLAINT. THIS APPEARS TO BE AN ISOLATED INCIDENT. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE CATHETER THAT WAS RETURNED FOR EVALUATION WAS FOUND TO HAVE A SILICONE ELASTOMER MATERIAL ON THE VASCULAR BALLOON LATEX THAT WAS NOT INDICATED ON THE ORIGINAL REPORT. ONE FOGARTY EMBOLECTOMY CATHETER WITH ATTACHED BD 1 CC SYRINGE AND STYLET WIRE WAS RECEIVED FOR EVALUATION. THE BALLOON AND BALLOON WINDINGS WERE VISUALLY INSPECTED FOR INDICATION OF DAMAGE OR ABNORMALITY AND THE BALLOON WAS FOUND TO BE RUPTURED LONGITUDINALLY BETWEEN THE DISTAL AND PROXIMAL WINDINGS. A TRANSPARENT GUMMY MATERIAL, 7/100' X 1/50' LONG, ON THE BALLOON LATEX WAS OBSERVED. THERE DID NOT APPEAR TO BE ANY LATEX MISSING. THE SAMPLE MATERIAL WAS REMOVED AND SENT TO CHEMISTRY FOR FURTHER ANALYSIS. CHEMISTRY TESTING FOUND THE SUBSTANCE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARED TO SILASTIC (SILICONE ELASTOMERS) LIKE MATERIAL. NO DAMAGE TO THE BALLOON WINDINGS, CATHETER BODY, OR RETURNED SYRINGE WAS NOTED. THE FOREIGN MATERIAL WAS MEASURED WITH A LAB SCALE AND LAB MICROSCOPE AT 20X MAGNIFICATION. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION AND WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE IF THE ROOT CAUSE IS RELATED TO THE MANUFACTURING PROCESS AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT "THE BALLOON DID NOT INFLATE BEFORE USE." THE CATHETER WAS NOT USED AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67318 FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER FOGARTY CATHETER DXE EDWARDS LIFESCIENCES, PR 12TLW803F 59251600

    Patients

    Seq Age Sex Outcome Treatment
    1