BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1891989 · Received November 6, 2010

    Report

    Report Number
    2015691-2010-14331
    Event Type
    Malfunction
    Date Received
    November 6, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 8, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PACKAGING TUBE IS BROKEN AT THE BOND SITE, BETWEEN THE CLEAR ADAPTOR AND THE GRAY TUBE. THE CATHETER IS EXPOSED THROUGH THE BROKEN PACKAGING. THE SHRINK SEALS ARE STILL ATTACHED, ONE AT THE CLEAR ADAPTOR CAP AND THE OTHER AROUND THE DIRECTIONS FOR USE. WHEN THE CATHETER WAS PULLED OUT OF THE TUBE DURING EVALUATION, IT WAS FOUND TO BE IN GOOD CONDITION. ALTHOUGH THE REPORTED COMPLAINT WAS CONFIRMED, THERE WAS NO EVIDENCE OF A MANUFACTURING DEFECT. FURTHER INVESTIGATION REVEALED THAT THE PRODUCT WAS PACKED IN THE INCORRECT SHIPPING BOX, WHICH RESULTED IN DAMAGE TO THE PRODUCT PACKAGE DURING SHIPPING. THE PACKER WHO PACKED THIS SHIPMENT HAS SINCE BEEN RE-TRAINED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTEDLY, ALTHOUGH THE DEVICE WAS PACKAGED IN BUBBLE WRAP THE TUBE IS BROKEN AT ITS NECK (WHERE IT GOES FROM THICK TO THIN). IT WAS DISCOVERED WHEN THE CUSTOMER TRIED TO REMOVE IT FROM ITS PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES PR 120805F 58900151

    Patients

    Seq Age Sex Outcome Treatment
    1