BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXXCEL SOFT THIN WALL STR 6/10

    MDR report key: 1915446 · Received November 4, 2010

    Report

    Report Number
    2242352-2010-03242
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN FOR EVAL. EVAL METHOD: THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AS REQUIRED. ALL MFG AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH APPLICABLE QUALITY PROCEDURES. RESULTS: THE PRODUCTION BATCH RECORD FOR THIS PRODUCT SHOWS THAT IT WAS RELEASED IN ACCORDANCE WITH ALL GOVERNING QA/QUALITY CONTROL PROCEDURES PRIOR TO DISTRIBUTION. THERE ARE NO SIMILAR OR OTHER TYPES OF COMPLAINTS AGAINST THE BATCH. SUTURE RETENTION TESTING WAS PERFORMED ON THIS BATCH PRIOR TO RELEASE, AND THE PIECES TESTED WERE WITHIN SPECIFICATION. ITEMS MARKED AS NI ARE UNK TO US AT THIS TIME. IF ADD'L INFO IS RECEIVED, IT WILL BE SENT IN A F/U REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TYPE A DISSECTION PROCEDURE, WHILE STITCHING THE IMPLANT, THE SURGICAL SUTURES WERE PULLING OUT ON BOTH ENDS. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER PROSTHESIS WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXXCEL SOFT THIN WALL STR 6/10 VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC. 491016 12846392

    Patients

    Seq Age Sex Outcome Treatment
    1 NI