BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAGEN COATED POLYESTER VASCULAR GRAFT

    MDR report key: 1200043 · Received July 23, 2008

    Report

    Report Number
    1640201-2008-00012
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FACILITY NUMBER HAS BEEN ASSIGNED TO THIS REPORT. NO DEVICE EVALUATION WAS PERFORMED, SINCE PRODUCT WAS NOT YET RETURNED TO THE MANUFACTURER. A PRODUCT COATED DURING THE SAME PERIOD THAN THE COMPLAINT DEVICE WAS EVALUATED. THE VISUAL EXAMINATION PERFORMED BY THE QA/QC MANAGER EVIDENCED NO PRODUCT ANOMALY AND NO POOR COLLAGEN ADHERENCE. THE GRAFT WAS HANDLED WITH PRECAUTION: NO FRAYING WAS OBSERVED AND NO PIECES OF COLLAGEN WERE GENERATED. IN ADDITION, A WATER PERMEABILITY TESTING WAS PERFORMED ON THIS SAMPLE: THE RESULTS INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS, AND NO POOR COLLAGEN ADHERENCE WAS NOTICED. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORDS OF THE COMPLAINT DEVICE INDICATED THAT THE GRAFT WAS PROCESSED, AND INSPECTED ACCORDING TO PROCEDURES. SPECIFICALLY, THE COLLAGEN COATING RECORDS EVIDENCED NO ANOMALY. IN ADDITION, THE WATER PERMEABILITY TESTING PERFORMED ON A GRAFT FROM THE SAME BATCH NUMBER THAN THE COMPLAINT DEVICE INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS. NOTE THAT DURING THIS TESTING, ALSO DESIGNED TO ASSESS THE COLLAGEN ADHERENCE, NO POOR COLLAGEN ADHERENCE WAS NOTICED. CONCLUSION: NO CONCLUSION CAN BE DRAWN UNTIL THE COMPLAINT DEVICE IS RECEIVED AND EVALUATED. HOWEVER, INITIAL INVESTIGATION WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT OF ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ABDOMINAL VASCULAR REPLACEMENT PROCEDURE. DURING SURGERY, THE PHYSICIAN HANDLED THE GRAFT AND NOTICED THE COLLAGEN COATING PEELED OFF. THE GRAFT WAS NOT IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAGEN COATED POLYESTER VASCULAR GRAFT DSY INTERVASCULAR IGK1407 04L04

    Patients

    Seq Age Sex Outcome Treatment
    1