BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMABRIDGE WOVEN GRAFT

    MDR report key: 3934642 · Received June 25, 2014

    Report

    Report Number
    1640201-2014-00021
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 3, 2014
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K013651
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFORMATION CONTAINED IN THIS REPORT IS PROVIDED BY THE MANUFACTURER. ((B)(4)) A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING COLLAGEN COATING RECORDS, INDICATED THAT THE PRODUCT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, THE REVIEW OF THE WATER PERMEABILITY TESTING OF PRODUCTS COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. (B)(4) ONE RETENTION SAMPLE COATED ON THE SAME PERIOD AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE UNDERWENT WATER PERMEABILITY TESTING AT 120MMHG AS PER ISO 7198. THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS. NO CONCLUSION CAN BE DRAWN. HOWEVER, ALL AVAILABLE INFORMATION WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS PERFORMED ON (B)(6) 2014, BLEEDING OCCURRED FROM THE CONNECTING PART OF THE GRAFT. THE SURGERY WAS COMPLETED BY WRAPPING THE GRAFT WITH A PATCH AND SUTURING IT. THE GRAFT REMAINED IMPLANTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371144 HEMABRIDGE WOVEN GRAFT VASCULAR GRAFT PROSTHESIS DSY INTERVASCULAR HEW2410BRIDGE 12F21

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other