BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 2882740 · Received December 20, 2012

    Report

    Report Number
    2015691-2012-18912
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 29, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED IN A BROKEN SHIPPING TUBE. THE EVALUATION INCLUDED VISUAL EXAMINATION, AND NOTATION OF ANY ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE CATHETER WAS RECEIVED IN A BROKEN SHIPPING TUBE. THE CLEAR ADAPTOR IS BROKEN AT THE CONNECTION WITH THE GRAY TUBE. THE SHRINK SEALS ARE STILL ATTACHED, ONE AT THE CLEAR ADAPTOR CAP AND THE OTHER AROUND THE IFU. THE RETURNED OUTER RECTANGULAR BOX ((B)(4)) DOES NOT APPEAR TO BE THE SAME BOX IN WHICH THE CUSTOMER RECEIVED THE CATHETER. THE CATHETER APPEARS TO BE IN GOOD CONDITION, ALTHOUGH STERILITY HAS BEEN COMPROMISED. 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 TUBING BROKE IN THE AREA WHERE THE IFU IS ATTACHED TO THE SHIPPING TUBE. THE PRODUCT WAS NOT USED AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES, PR 120805F 59152566

    Patients

    Seq Age Sex Outcome Treatment
    1