BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMAGARD KNITTED VASCULAR GRAFT

    MDR report key: 2885327 · Received December 18, 2012

    Report

    Report Number
    1640201-2012-00052
    Event Type
    Other
    Date Received
    December 18, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 19, 2012
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING COLLAGEN COATING RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, THE REVIEW OF THE WATER PERMEABILITY TESTING OF SIX PRODUCTS COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE INDICATES VALUES WELL WITHIN PRODUCT SPECIFICATIONS. ONE RETENTION SAMPLE COATED DURING THE SAME PERIOD AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE UNDERWENT WATER PERMEABILITY TESTING AT 120MMHG AS PER ISO 7198. THE TEST RESULTS INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS. CONCLUSION: PLEASE NOTE THAT THE DEVICE WAS NOT USED IN AN APPROVED INDICATION. NO CONCLUSION CAN BE DRAWN. HOWEVER, ALL AVAILABLE INFORMATION AND THE PRODUCT TESTING PERFORMED WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE GRAFT WAS USED FOR AXILLARY CANNULATION. THROUGHOUT THE PROCEDURE, THE GRAFT WAS REPORTED TO LEAK. THE SURGERY WAS PROLONGED BY ONE HOUR AND THE PATIENT LOST 3-4 UNITS OF BLOOD, WHICH NECESSITATED BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579466 HEMAGARD KNITTED VASCULAR GRAFT DSY INTERVASCULAR IGK0008-70 10K28

    Patients

    Seq Age Sex Outcome Treatment
    1