BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAGARD KNITTED

    MDR report key: 6766625 · Received August 4, 2017

    Report

    Report Number
    1640201-2017-00028
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    July 7, 2017
    Report Date
    August 4, 2017
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION E2017024 : INTERVASCULAR SAS (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF MAQUET CARDIOVASCULAR, LLC (IMPORTER). (10/3317/213) A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. SPECIFICALLY, NO ANOMALY WAS EVIDENCED IN THE COLLAGEN COATING RECORDS. THE REVIEW OF THE WATER PERMEABILITY TESTING RECORDS OF PRODUCTS COATED ON THE SAME DAY AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. PLEASE NOTE THAT WATER PERMEABILITY TESTING IS RECOGNIZED BY INTERNATIONAL STANDARD FOR VASCULAR GRAFTS AS THE TEST TO ADDRESS THE RISK OF BLOOD LEAKAGE. (3340/3345/213) ONE RETENTION SAMPLE COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE INVOLVED DEVICE UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). (11) THE INVESTIGATION IS STILL ONGOING. IT WAS REPORTED THAT THE GRAFT IS AVAILABLE FOR EVALUATION, IT SHOULD BE RETURNED. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A BYPASS PROCEDURE AFTER THE GRAFT WAS UNCLAMPED, BLOOD WAS POURING OUT OF HOLES IN THE GRAFT BEYOND NORMAL BLUSHING. THE PRODUCT WAS NOT IMPLANTED. A COMPETITOR EPTFE GRAFT WAS USED AS A REPLACEMENT TO COMPLETE THE CASE. THE PATIENT IS IN GOOD CONDITION.

    Additional Manufacturer Narrative · 1

    THE GRAFT WAS AVAILABLE FOR INVESTIGATION. IT WAS SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE PRESENCE OF ANY STRUCTURAL ABNORMALITY VISIBLE ON THE EXTERNAL SIDE OF THE RETURNED VASCULAR GRAFT. THE ANALYSIS CONSISTED OF A MACROSCOPIC OBSERVATION OF THE GRAFT AND A SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS. THE SEM ANALYSIS POINTED OUT SOME INFILTRATION OF COLLAGEN MATERIAL WITH NO SIGNIFICANT ABNORMALITY SUCH AS TEARS, LOSS OF TEXTILE COHESION, HOLES AND SIGNS OF CUT. THE SEM ANALYSIS CORROBORATED THE MACROSCOPIC ANALYSIS. NO CONCLUSION CAN BE DRAWN. HOWEVER, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED WOULD TEND TO INDICATE THAT THE PRODUCT WAS NOT DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546509 HEMAGARD KNITTED VASCULAR POLYESTER GRAFT DSY INTERVASCULAR SAS HGK0007-100 13L28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention