BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAGARD KNITTED

    MDR report key: 6972795 · Received October 24, 2017

    Report

    Report Number
    1640201-2017-00034
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 24, 2017
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401014812
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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). (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. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN AXILLO-BIFEMORAL CASE, AFTER THE PHYSICIAN TOOK CLAMPS OFF, IMMEDIATELY BLOOD STARTED WEEPING PROFUSELY THROUGH THE HEMAGARD GRAFT. THE PATIENT HAD 10,000 UNITS OF HEPARIN IN THE BEGINNING OF THE PROCEDURE AND AN ADDITIONAL 2000 UNITS OF HEPARIN MID PROCEDURE. THE MEDICAL STAFF AND PHYSICIAN CHOSE NOT TO REVERSE HEPARIN. THE BLOOD LEAKING STOPPED AFTER 20 MINUTES. THE GRAFT REMAINED IMPLANTED AND THE PATIENT WAS STABLE. IT WAS ALSO REPORTED THAT THIS WAS PHYSICIAN'S FIRST CASE USING AN HEMAGARD GRAFT.

    Additional Manufacturer Narrative · 1

    (B)(4) 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. 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
    752114 HEMAGARD KNITTED VASCULAR POLYESTER GRAFT DSY INTERVASCULAR SAS HGKAX0808RS45/30 13D11 00384401014812

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other