BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMABRIDGE WOVEN VASCULAR GRAFT

    MDR report key: 2922218 · Received January 14, 2013

    Report

    Report Number
    1640201-2013-00002
    Event Type
    Other
    Date Received
    January 14, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 17, 2012
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K013651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIDE BRANCH OF THE COMPLAINT DEVICE WA SENT TO AN OUTSIDE LAB FOR SCANNING ELECTRON MICROSCOPY ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING COLLAGEN COATING RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED ADN INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, THE REVIEW OF THE WATER PERMEABILITY TESTING OF SEVEN 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 F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2012, BLEEDING WAS OBSERVED THROUGH THE SIDE BRANCH OF THE GRAFT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19870 HEMABRIDGE WOVEN VASCULAR GRAFT DSY INTERVASCULAR HEW3010BRIDGE 11B03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other