BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORETURN FEMORAL CANNULA

    MDR report key: 3021994 · Received March 26, 2013

    Report

    Report Number
    3008500478-2013-00413
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K962858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. THE PATIENT WAS (B)(6) AND THE HOSPITAL IS UNABLE TO RELEASE DEVICE FOR EVALUATION. THE PRODUCT WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS DEVICE. THEREFORE A CAPA WILL NOT BE INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING ADN FUTURE CAPA DETERMINATIONS. THE HOSPITAL IS ALSO REQUESTING A FEATURE ON THIS DEVICE THAT CURRENTLY IS NOT IN EXISTENCE. THIS INFORMATION WILL BE RELAYED TO THE R&D DEPARTMENT FOR ADDITIONAL ENHANCEMENT CONSIDERATION.

    Description of Event or Problem · 1

    IT WAS PHONED IN BY THE SALES REP THAT THERE WAS A FEMORAL DISSECTION LIKELY CAUSED BY THE ENDRETURN ER23B OPTURATOR. THE DR. BELIEVED "SINCE THE DEVICE DOES NOT LOCK IN PLACE AS IT MOVED BACK THE CANNULA CAUSED INJURY TO THE INTIMA". PHYSICIAN STATED NO PRODUCT MALFUNCTION. PROCEDURE CONVERTED TO OPEN STERNOTOMY, REPAIR TO VESSEL MADE AND PT DOING WELL. PT HAS HISTORY OF SEVERE IV DRUG ABUSE, "SIGNIFICANT" PRIOR VESSEL DAMAGE. HX: (B)(6) MALE, CAD, 1 VESSEL BYPASS. PATIENT HAS (B)(6) AND DEVICES NOT ABLE TO BE RETURNED PER HOSPITAL PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123809 ENDORETURN FEMORAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES ER23

    Patients

    Seq Age Sex Outcome Treatment
    1 40