BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1870027 · Received October 15, 2010

    Report

    Report Number
    2015691-2010-14202
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE CATHETER WAS RETURNED WITHOUT THE PACKAGING FOR EVALUATION. THE REPORTED DEFECT WAS CONFIRMED FOR BALLOON DAMAGE. THE EVALUATION INCLUDED VISUAL EXAMINATION FOR ANY DAMAGED, INCORRECT OR MISSING COMPONENTS; CONTAMINATION; OR IMPROPER LABELING; INSPECTION OF THE BALLOON AND BALLOON WINDINGS/BONDS FOR INDICATION OF DAMAGE OR ABNORMALITY. THE PROXIMAL AND DISTAL WINDINGS HAVE BEEN PULLED OFF THE DISTAL TIP OF THE CATHETER, AND WERE NOT RETURNED. THE BALLOON LATEX IS ALSO MISSING. THIS CONDITION MAY OCCUR WHEN THE PULL FORCE OF 1.5 LBS (PER DFU) HAS BEEN EXCEEDED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTEDLY, THERE WAS LEAKAGE (BALLOON) IN THE CATHETER DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES PR 120404F 58818898

    Patients

    Seq Age Sex Outcome Treatment
    1