BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD VASCULAR GRAFTS

    MDR report key: 2099458 · Received May 13, 2011

    Report

    Report Number
    2242352-2011-00413
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    May 24, 2010
    Report Date
    April 19, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THE STATUS OF THE DEVICE REMAINS UNKNOWN. A DHR AND BATCH TREND ANALYSIS COULD NOT BE PERFORMED BASED ON THE LACK OF UPN, AND ON THE BATCH NUMBER PROVIDED, WHICH WE ARE CERTAIN IS NOT A HEMASHIELD BATCH NUMBER. FOLLOWING OUR INVESTIGATION, DUE TO THE LACK OF INFORMATION, OUR CONCLUSION TO THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. MULTIPLE REQUESTS WERE MADE TO GATHER ADDITIONAL INFORMATION INCLUDING EVENT DESCRIPTIONS, PROCEDURE INFORMATION, PRODUCT IDENTIFICATION, AS WELL AS IF PRODUCT, OR PORTION OF THE PRODUCT WAS AVAILABLE FOR EVALUATION. UNFORTUNATELY, DUE TO THE CONFIDENTIALITY THAT (B)(6) ((B)(6)'S REGULATORY AUTHORITY) HAS PLACED ON BOSTON SCIENTIFIC (B)(6), ADDITIONAL INFORMATION WAS NOT PERMITTED TO BE SHARED WITH MAQUET CARDIOVASCULAR, LLC. ADDITIONALLY, BASED ON THAT SAME CONFIDENTIALITY, MAQUET (B)(6) IS UNABLE TO REQUEST ADDITIONAL INFORMATION DIRECTLY FROM (B)(6), AS BOSTON SCIENTIFIC IS BEING RECOGNIZED AS THE LEGAL MANUFACTURER OF THE DEVICE. NOTE: ITEMS MARKED "NI" ARE NOT ATTAINABLE AT THIS TIME. SHOULD SUCH INFORMATION BECOMES AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (B)(6) RECEIVED INFORMATION OF A COMPLAINT ABOUT A HEMASHIELD PRODUCT ON (B)(4) 2011. THIS COMPLAINT WAS DIRECTLY REPORTED BY THE CUSTOMER TO (B)(6) ((B)(6)'S REGULATORY AUTHORITY). BOSTON SCIENTIFIC (B)(6) FORWARDED THE COMPLAINT TO A MAQUET REP IN (B)(6) SINCE THEY NO LONGER MFR HEMASHIELD. THE EVENT DESCRIPTION PROVIDED WAS "FEVER IN IMMEDIATE POSTOPERATIVE PLACEMENT OF AORTIC VALVE TUBE PROSTHESIS IN (B)(6) 2010." THERE WAS NO DEATH OR TEMPORARY LESIONS. THE UPN WAS NOT PROVIDED. THE REPORTED BATCH OF 81433668 IS NOT A RECOGNIZED MAQUET CARDIOVASCULAR, LLC BATCH NUMBER. WE ARE CURRENTLY USING AN EIGHT DIGIT BATCH IDENTIFICATION SEQUENCE, BUT WE HAVE NOT REACHED THAT HIGH OF A NUMBER AT THIS TIME. PREVIOUSLY, WE WERE USING SIX AND SEVEN DIGIT BATCH NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD VASCULAR GRAFTS VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI