BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 2800208 · Received October 22, 2012

    Report

    Report Number
    2015691-2012-18518
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    ONE EMBOLECTOMY CATHETER WAS RECEIVED INSIDE A BROKEN SHIPPING TUBE. THE OUTER BOX WAS ALSO RECEIVED AND EXAMINED PRIOR TO DECONTAMINATION AND WAS FOUND NOT TO BE DAMAGED. THE EVALUATION INCLUDED VISUAL EXAMINE, AND NOTE ANY OBSERVED ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE CATHETER WAS RECEIVED IN A BROKEN SHIPPING TUBE. THE GRAY TUBE IS BROKEN 23CM PROXIMAL OF THE BOTTOM OF THE GRAY TUBE. THE SHRINK SEALS WERE STILL ATTACHED, ONE AT THE CLEAR ADAPTOR CAP AND THE OTHER AROUND THE IFU. THE RETURNED OUTER RECTANGULAR BOX DOES NOT APPEAR TO BE THE SAME BOX DAMAGED WHEN THE CUSTOMER RECEIVED THE PRODUCT. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE COMPLAINT WAS CONFIRMED AND APPEARS TO BE RELATED TO SHIPPING OF THE PRODUCT. AN INVESTIGATION IS CURRENTLY UNDERWAY TO DETERMINE THE VARIABLES THAT CAN IMPACT THE PRODUCT DURING SHIPPING, IN AN EFFORT TO REDUCE COMPLAINTS OF THIS TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHIPPING TUBE WAS BROKEN/SNAPPED. THE SHIPPING TUBE WAS OBSERVED TO BE BROKEN WHEN RECEIVED IN THE OPERATING ROOM. THE CATHETER WAS NOT USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES, PR 120602F 59320194

    Patients

    Seq Age Sex Outcome Treatment
    1