BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMAGARD KNITTED GRAFT

    MDR report key: 3772370 · Received March 6, 2014

    Report

    Report Number
    1640201-2014-00005
    Event Type
    Other
    Date Received
    March 6, 2014
    Report Date
    February 7, 2014
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT RELATES TO ONE OF THE TWO PRODUCTS INVOLVED IN THE EVENT. THE REPORT #1640201-2014-00004 RELATES TO THE OTHER INVOLVED PRODUCT. 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 TWELVE PRODUCTS COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. THE INVESTIGATION IS STILL ON GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN OPEN AAA BYPASS PROCEDURE INVOLVING TWO VASCULAR PROTHESIS, ONE FOR BYPASS AND ONE FOR AUXILLIARY CANNULATION, BLEEDING OCCURED AT THE ANASTOMOSIS BETWEEN THE TWO PRODUCTS. THE PHYSICIAN INDICATED THAT 2 LITERS OF BLOOD PRODUCT WERE LOST DUE TO THIS LEAK, REQUIRING ADDITIONAL BLOOD PRODUCT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136967 HEMAGARD KNITTED GRAFT DSY INTERVASCULAR HGK0010-40 13G18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other