BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACROBAT SUV VACUUM OFF-PUMP SYSTEM

    MDR report key: 1241267 · Received November 21, 2008

    Report

    Report Number
    2953148-2008-00949
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    GUIDANT CARDAIC SURGERY
    Product Code
    MWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LOT HISTORY RECORD REVIEW CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE SURGEON CAUGHT THE LEFT INTERNAL MAMMARY ARTERY (LIMA) WITH THE EDGE/LIP OF THE STANDARD BLADE OF THE ACCESS RAIL PLATFORM (STERNAL RETRACTOR). THE SURGEON SLIGHTLY MODIFIED THE PROCEDURE BY COMPLETELY REMOVED THE MAMMARY ARTERY AND USING IT AS FREE GRAFT. AFTER HARVESTING THE MAMMARY ARTERY, THE SURGEON LEFT THE DISTAL PORTION ATTACHED AND POSITIONED THE STERNAL RETRACTOR. THE HOSPITAL REPORTED THAT THE PATIENT HAS RECOVERED WITHOUT ANY COMPLICATIONS. THERE WAS NO PRODUCT MALFUNCTION; HOWEVER, THE EVENT WILL BE FILED AS A SERIOUS INJURY SINCE MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO COMPLETE THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROBAT SUV VACUUM OFF-PUMP SYSTEM MWS GUIDANT CARDAIC SURGERY OM-9000S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention