BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCAS MEDICAL NON-LATEX EMBOLECTOMY CATHETER

    MDR report key: 2132929 · Received June 17, 2011

    Report

    Report Number
    2015691-2011-15736
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 19, 2011
    Manufacturer
    LUCAS MEDICAL, INC.
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED INSIDE A BROKEN SHIPPING TUBE. THE EVALUATION INCLUDED VISUAL EXAMINE, AND NOTE ANY OBSERVED ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE BALLOON AND BALLOON WINDINGS/BONDS WERE VISUALLY INSPECTED FOR INDICATION OF DAMAGE OR ABNORMALITY AND THERE WAS NO DAMAGE FOUND. THE CATHETER WAS RECEIVED IN A BROKEN SHIPPING TUBE. THE TUBE IS BROKEN 15.5 CM DISTAL OF THE GRAY TUBE TO CLEAR ADAPTOR BOND SITE. THE CATHETER IS ALSO HAS A SLIGHT BEND IN THE SAME LOCATION. THE SHRINK SEALS ARE STILL ATTACHED, ONE AT THE CLEAR ADAPTOR CAP AND THE OTHER AROUND THE IFU. THE BALLOON AND WINDINGS WERE FOUND TO BE IN GOOD CONDITION ALTHOUGH THE BALLOON WAS NOT INFLATED DUE TO THE CATHETER STILL SEALED INSIDE THE CLEAR ADAPTOR. THOUGH WE HAVE CONFIRMED A PRODUCT NONCONFORMANCE EXISTS, THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. THESE TYPES OF COMPLAINTS ARE CURRENTLY BEING INVESTIGATED TO DETERMINE THE ROOT CAUSE. PLEASE NOTE THAT THE CATHETER IS NOT AN EDWARDS MANUFACTURED DEVICE; HOWEVER, THE SHIPPING TUBE IS MANUFACTURED BY EDWARDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTSIDE GRAY TUBES WERE SNAPPED IN HALF UP WHEN RECEIVED IN THE OPERATING ROOM. THERE WERE NO PATIENT COMPLICATIONS. THESE UNITS ARE ORDERED AND SHIPPED TO THE CUSTOMERS THROUGH EDWARDS LIFESCIENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUCAS MEDICAL NON-LATEX EMBOLECTOMY CATHETER NON-LATEX BALLOON EMBOLECTOMY CATHETER DXE LUCAS MEDICAL, INC. NL3EMB80T F3986

    Patients

    Seq Age Sex Outcome Treatment
    1