BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN TICRON

    MDR report key: 3924773 · Received July 1, 2014

    Report

    Report Number
    9612501-2014-00205
    Event Type
    Death
    Date Received
    July 1, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GAP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COMPLAINT RELATED TO THE SAME INCIDENT UNDER (B)(4). PROCEDURE TYPE: MITRAL RECONSTRUCTION. ACCORDING TO THE REPORTER: SURGEON INFORMS THAT THE SUTURES BREAK (TEAR), THE NEEDLES HAVE NO CONSISTENCY AND THEY ARE DIFFICULT TO MANIPULATE. DUE TO THIS ISSUE, THE PATIENT REMAINED 60 ADDITIONAL MINUTES WITH ISCHEMIA IN THE HEART. NOW THE PATIENT HAS AN ARTIFICIAL HEART AND IS ABOUT TO DIE. MORE THAN 30 MINUTES DELAY DUE TO THE PROBLEM. DAMAGED TO TISSUE. ADDITIONAL INFORMATION RECEIVED: THE SALES REGIONAL MANAGER AND THE FIELD SERVICE MANAGER MET WITH THE SURGEON. ACCORDING TO THE SURGEON, THE PROBLEM IS NOT IN FACT A QUALITY PROBLEM WITH THE SPECIFIC LOT OF SUTURE USED DURING THE PROCEDURE, BUT A COMPLAINT ON THE INADEQUACY OF THIS TYPE OF SUTURE AND MODEL ACCORDING TO THE SURGEONS CRITERIA. HE REPORTED THAT THE PLEDGETS ARE FRAYED, AND THE SILICON COATING SEEMS OF LOW QUALITY. THE LENGTH OF 90CM WAS NOT ADEQUATE AND HE NEEDS 75CM LENGTH WITH 10 THREADS. THE PATIENT WAS DISCONNECTED, ALTHOUGH THE DEATH CANNOT BE ATTRIBUTED DIRECTLY TO THE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381601 UNKNOWN TICRON UNK GAP COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death