BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 1994359 · Received January 14, 2011

    Report

    Report Number
    2242352-2010-03999
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III PROXIMAL SEAL WOULD NOT FOLD. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR LLC HSK-3038 25019487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA