BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERGARD HEPARIN KNITTED RADIALLY SUPPORTED

    MDR report key: 1960279 · Received January 7, 2011

    Report

    Report Number
    1640201-2010-00033
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 10, 2010
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K990800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFO CONTAINED IN THIS REPORT WAS PROVIDED BY THE MFR. NO FACILITY NUMBER HAS BEEN ASSIGNED TO THIS REPORT. NO PRODUCT EVAL WAS PERFORMED SINCE THE GRAFT REMAINED IMPLANTED IN THE PT. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, NO ANOMALY WAS FOUND IN THE COLLAGEN COATING RECORDS. THE REVIEW OF THE WATER PERMEABILITY TESTING OF SEVEN PRODUCTS INDICATED VALUES WELL WITHIN PRODUCT SPECS. A RETENTION SAMPLE COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE UNDERWENT WATER PERMEABILITY TESTING. TEST RESULT INDICATED A VALUE WELL BELOW PRODUCT SPECS. NO CONCLUSION CAN BE DRAWN. HOWEVER, PRODUCT TESTING PERFORMED ON SIMILAR PRODUCTS WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE.

    Description of Event or Problem · 1

    PT UNDERWENT A FEMORAL/DISTAL BYPASS PROCEDURE ON (B)(6) 2010. IT WAS REPORTED A BLOOD LEAKING FROM THE FIRST 1-2 INCHES OF THE PROXIMAL END OF THE GRAFT. ADD'L CLAMPING TIME WAS NEEDED AND HEMOSTATIC AGENTS WERE USED TO STOP BLEEDING. SURGERY WAS REPORTED TO HAVE BEEN PROLONGED BY 40 MINUTES. THE GRAFT REMAINED IMPLANTED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD HEPARIN KNITTED RADIALLY SUPPORTED DSY INTERVASCULAR IGKUT0006RS45H 10D29

    Patients

    Seq Age Sex Outcome Treatment
    1 Other