BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 3903405 · Received June 30, 2014

    Report

    Report Number
    2015691-2014-01490
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE EMBOLECTOMY CATHETER WAS RETURNED FOR EVALUATION WITHOUT THE PACKAGING. AS RECEIVED THE CATHETER TIP WAS DAMAGED. THE DISTAL WINDINGS, SPRING TIP AND BALLOON LATEX WERE FOUND TO BE MISSING FROM THE CATHETER TIP. THE BALLOON LATEX AND BOTH DISTAL WINDINGS AND THE SPRING TIP WERE NOT RETURNED. THIS CONDITION MAY OCCUR WHEN THE PULL FORCE OF 0.7 LBS ON AN INFLATED BALLOON (PER IFU) HAS BEEN EXCEEDED. NO VISIBLE DAMAGE TO THE CATHETER BODY WAS FOUND. VISUAL EXAMINATION WAS PERFORMED WITH THE UNAIDED EYES. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TIP OF THE CATHETER REMAINED IN THE PATIENT PERIPHERAL SITE DURING USE. THE CATHETER WAS USED FOR THROMBECTOMY IN THE LEFT DEEP FEMORAL ARTERY. STRONG RESISTANCE WAS FELT, SO SALINE INSIDE THE BALLOON WAS ASPIRATED BY THE SYRINGE TO DEFLATE THE BALLOON. THE CATHETER MOVED TO PERIPHERAL SITE WITH BLOOD FLOW. RESISTANCE WAS STILL FELT AND IT WAS UNABLE TO REMOVE THE CATHETER, SO THE CUSTOMER PULLED THE CATHETER WITH FORCE, THEN THE SPRING TIP GOT DETACHED AND IT REMAINED IN THE PATIENT PERIPHERAL SITE. THE DOCTOR COMMENTED THAT SINCE THE FRAGMENT HAD FLOWED TO PERIPHERAL SITE AND THE BLOOD FLOW WAS CONFIRMED, THE FRAGMENT WAS NOT REMOVED SURGICALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379239 FOGARTY ARTERIAL EMBOLECTOMY CATHETER FOGARTY CATHETER DXE EDWARDS LIFESCIENCES, PR 120803F 59625846

    Patients

    Seq Age Sex Outcome Treatment
    1