BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY II CATHETER

    MDR report key: 2685951 · Received August 7, 2012

    Report

    Report Number
    2015691-2012-18032
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    K901625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MODEL NO. 140808 ADHERENT CLOT CATHETER WAS RECEIVED, INSIDE ONE SHIPPING TUBE. THE CATHETER WAS RECEIVED IN A BROKEN SHIPPING TUBE. THE WHITE SHIPPING TUBE WAS BROKEN AT THE BOND SITE AT THE CLEAR ADAPTOR. THE SHRINK SEAL WAS STILL ATTACHED AT THE CLEAR ADAPTOR CAP. THE PRODUCT STERILITY HAD BEEN COMPROMISED. CATHETER WAS REMOVED FROM THE TUBE AND FOUND KINKED AT 82 CM AREA, WHICH MATCHED UP AT THE BREAK SITE. THERE WAS NO OTHER VISIBLE INCONSISTENCIES OBSERVED. 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 TWO CATHETERS WERE RECEIVED AND ONE OF THE CATHETERS WAS DAMAGED, THE SHIPPING TUBE WAS BROKEN AT THE CLEAR ADAPTOR AND THE GREY TUBE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY II CATHETER ADHERENT CLOT CATHETER DXE EDWARDS LIFESCIENCES, PR 140808 59255347

    Patients

    Seq Age Sex Outcome Treatment
    1