BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1932614 · Received December 19, 2010

    Report

    Report Number
    2015691-2010-14539
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CATHETER WAS RECEIVED IN A BROKEN SHIPPING TUBE. THE CLEAR ADAPTOR IS BROKEN WHERE THE GRAY SHIPPING TUBE ENDS. THE SHRINK SEALS ARE STILL ATTACHED, ONE AT THE CLEAR ADAPTOR CAP AND THE OTHER AROUND THE DFU. WHEN THE CATHETER WAS PULLED OUT OF THE TUBE, IT WAS FOUND TO BE BENT AT THE ADAPTOR BREAK SITE. THE BALLOON AND WINDINGS WERE FOUND TO BE IN GOOD CONDITION. ALTHOUGH THE REPORTED DEFECT WAS CONFIRMED, THERE IS NO EVIDENCE OF A MANUFACTURING DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS RECEIVED BROKEN WHERE THE CLEAR TUBE MEETS THE GREY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES PR 120805F 58917758

    Patients

    Seq Age Sex Outcome Treatment
    1