BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS AORTIC CANNULA, STRAIGHT BEVELED TIP

    MDR report key: 2061171 · Received April 18, 2011

    Report

    Report Number
    3008500478-2011-00084
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K831769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CHEMICAL ANALYSIS. DEVICE EVALUATION: RESULTS OF INVESTIGATION: THE SPC2145 DEVICE WAS EVALUATED BY THE PRODUCT EVALUATION LAB IN B)(4) WITH THE FOLLOWING REPORT: ''RECEIVED (1) 24FR AORTIC PERFUSION CANNULA IN OPEN ORIGINAL PACKAGE. CANNULA APPEARED NOT USED. THE EXTRA LAYER OF CLEAR UNKNOWN MATERIAL WAS FOUND ATTACHED TO CANNULA BODY, APPROXIMATELY 2.7" PROXIMAL FROM CANNULA TIP. THE AREA OF UNKNOWN MATERIAL WAS APPROXIMATELY 0.8"X0.1." A SMALL AREA OF THE LAYER PARTIALLY PEELED UP FROM THE CANNULA SURFACE. SAMPLE OF THE MATERIAL WAS REMOVED AND SENT TO CHEMISTRY FOR ANALYSIS. THE REST OF THE MATERIAL AND CANNULA WAS SENT TO UTAH FOR FURTHER EVALUATION. ON B)(4) 2011 PER CHEMISTRY STUDY, THE IR SPECTRUM OF THE UNKNOWN CLEAR MATERIAL REMOVED FROM THE SURFACE OF AORTIC CANNULA SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO POLYETHYLENE TEREPHTHALATE LIKE MATERIAL. THE SPC2145 DEVICE WAS EVALUATED BY MANUFACTURING ENGINEERING AND QUALITY ENGINEERING AT EDWARDS B)(4). THE CUSTOMER EXPERIENCE REPORT WAS CONFIRMED. THE PIECE OF UNKNOWN MATERIAL WAS ON THE CANNULA BUT NOT EMBEDDED INTO THE CANNULA WALL. THE UNKNOWN MATERIAL WAS LOCATED WHERE THE PACKAGING TRAY IS IN CONTACT WITH THE CANNULA. THE PACKAGING TRAY FOR THIS PRODUCT IS MADE OF POLYETHYLENE TEREPHTHALATE (PETE). PER EDWARDS B)(4) EVALUATION, THE IR SPECTRUM OF THE UNKNOWN MATERIAL SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO A POLYETHYLENE TEREPHTHALATE LIKE MATERIAL. THE PACKAGING WAS NOT RETURNED AND COULD NOT BE EVALUATED FOR DAMAGE. IT IS LIKELY THAT A PIECE OF THE PRODUCTS PACKAGING TRAY IS THE UNKNOWN MATERIAL. CATHETER IS NOT DAMAGED AND NO MANUFACTURING DEFECTS WERE OBSERVED. A DEVICE HISTORY REVIEW OF LOT 58931618 WAS CONDUCTED AND NO NONCONFORMITIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. MFG DATE= 12/22/10; EXPR DATE= 10/01/13. THE MATERIAL APPEARS TO HAVE COME FROM THE PACKAGING TRAY; ROOT CAUSE CANNOT BE DETERMINED. STORAGE CONDITIONS AND PRODUCT REMOVAL TECHNIQUES COULD HAVE ATTRIBUTED TO TRAY BREAKAGE. THE ISSUE IS AN ISOLATED INCIDENT AND IS NOT A CONFIRMED MANUFACTURING DEFECT THEREFORE A CAPA WILL NOT BE INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL PIECE OF SHARP PLASTIC WAS ADHERED TO THE CANNULA. NOTICED AFTER REMOVAL FROM PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS AORTIC CANNULA, STRAIGHT BEVELED TIP AORTIC CANNULA DWF EDWARDS LIFESCIENCES SPC2145 58931618

    Patients

    Seq Age Sex Outcome Treatment
    1