BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1063385 · Received June 19, 2008

    Report

    Report Number
    2024168-2008-00497
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - QUALITY ENGINEERING REVIEWED THE INCIDENT INFORMATION. THE DEVICE WAS IN WORKING ORDER AND LEFT ABBOTT VASCULAR AS PER SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THEREFORE, NO ROOT CAUSE CAN BE IDENTIFIED. NO DEVICE MALFUNCTION CAN BE DETERMINED DUE TO THE LACK OF PROCEDURE AND PATIENT INFORMATION AND THE LACK OF DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: REQUIRED MEDICAL INTERVENTION TO TREAT PERFORATION. DEVICE ISSUE: GRAFTMASTER WAS UNABLE TO CROSS THE LESION. IT WAS REPORTED THAT THE CASE INVOLVED A LESION IN THE MID LAD AND IT WAS A ROTABLATOR CASE, USING A ROTOWIRE. THE ROTABLATOR CAUSED A PERFORATION AND ALL THREE GRAFTMASTERS COULD NOT CROSS TO SEAL THE PERFORATION. THE ROTOWIRE WAS REMOVED AND REPLACED WITH A WHISPER GUIDE WIRE AND THEN FOUR (4) VISION STENTS WERE IMPLANTED TO TREAT THE PERFORATION. A PERICARDIOCENTESIS WAS ALSO PERFORMED. THERE WAS NO NEED FOR SURGERY. THE PATIENT IS DOING WELL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 506872

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention GUIDEWIRE:ROTOWIRE| WHISPER| STENT: VISION (X4)| OTHER: ROTABLATOR