BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 2171869 · Received July 22, 2011

    Report

    Report Number
    2015691-2011-15902
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE EMBOLECTOMY CATHETER WAS RECEIVED INSIDE A BROKEN SHIPPING TUBE. THE CATHETER ALSO WAS RETURNED WITH THE OUTER CARDBOARD BOX. THE EVALUATION INCLUDED VISUAL EXAMINATION, AND NOTE ANY OBSERVED ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE BALLOON AND BALLOON WINDINGS WERE VISUALLY INSPECTED FOR INDICATION OF DAMAGE OR ABNORMALITY AND THERE WAS NO DAMAGE FOUND. THE CATHETER WAS RECEIVED IN A BROKEN AND BENT SHIPPING TUBE. THE TUBE WAS BROKEN 28.5CM PROXIMAL OF THE DISTAL TIP OF THE GRAY SHIPPING TUBE. THE SHRINK SEALS WAS STILL ATTACHED, ONE AT THE CLEAR ADAPTOR CAP AND THE OTHER AROUND THE IFU. THE BALLOON AND WINDINGS WERE FOUND TO BE IN GOOD CONDITION. THE OUTER CARDBOARD BOX IS BENT AND CRUSHED AT THE SAME LOCATIONS AS THE DAMAGED CATHETER GRAY TUBE. ALTHOUGH WE HAVE CONFIRMED A PRODUCT NONCONFORMANCE EXISTS, THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. THESE TYPES OF COMPLAINTS ARE CURRENTLY BEING INVESTIGATED TO DETERMINE THE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOX APPEARED BENT/CREASED. WHEN THE CATHETER WAS REMOVED FROM THE BOX THE TUBE WAS BROKEN IN ONE PLACE AND BENT IN ANOTHER SPOT. IT WAS INDICATED THAT THE TUBE WAS WRAPPED IN BUBBLE WRAP. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES, PR 120805F 59000117

    Patients

    Seq Age Sex Outcome Treatment
    1