BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYS 3.8MM

    MDR report key: 3912147 · Received May 13, 2014

    Report

    Report Number
    2242352-2014-00559
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE AORTIC CUTTER ON THE HEARTSTRING III DID NOT CREATE A PROPER AORTOTOMY. IT WAS NOT SPHERICAL AND THE EDGES WERE SHREDDED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285316 HS III PROXIMAL SEAL SYS 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038

    Patients

    Seq Age Sex Outcome Treatment
    1