BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2863911 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07807
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SAPHENOUS VEIN GRAFT. A PERFORATION WAS CAUSED BY AN UNKNOWN BALLOON CATHETER. A 4.0 X 26 MM GRAFTMASTER WAS ADVANCED TO THE LESION; HOWEVER, IT WOULD NOT CROSS. THE DEVICE WAS REMOVED AND A TWO OTHER 3.5 X 12 MM GRAFTMASTERS WERE ADVANCED TO THE LESION AND THE PERFORATION WAS SEALED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 648390

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention