BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXXCEL SOFT THIN WALL STR EXT S 8/70/70

    MDR report key: 2901593 · Received January 4, 2013

    Report

    Report Number
    2242352-2012-01404
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K962433
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN AXILLOFEMORAL POPLITEAL BYPASS PROCEDURE, THE RING OF THE EXXCEL SOFT THIN WALL GRAFT UNRAVELED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4266 EXXCEL SOFT THIN WALL STR EXT S 8/70/70 VASCULAR GRAFT GEI MAQUET CARDIOVASCULAR, LLC 493078 25056337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA