BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SURGIPRO

    MDR report key: 3924743 · Received July 1, 2014

    Report

    Report Number
    1219930-2014-00494
    Event Type
    Death
    Date Received
    July 1, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GAS
    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: THE 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 INFO REQUESTED VIA EMAIL: THE SALES REGIONAL MANAGER AND FIELD SERVICE MANAGER HAVE VISITED THE SURGEON. ACCORDING TO THE SURGEON, THE PROBLEM IS NOT A 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 NEEDLES ARE NOT VISIBLE, THEY BLEND AND THEY ARE NOT CONSISTENT AND THE FORM IS NOT ADEQUATE FOR HIS NEEDS. SURGIPRO SIZE 4-0 HAS A VERY BIG NEEDLE, THE NEEDLE IS 1 MM SHORTER, AND THEREFORE LESS PRECISE. THE THREAD IS TOO LONG, AS IT SEPARATES FROM THE NEEDLE AND TEARS THE TISSUE ETC. 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
    381599 UNKNOWN SURGIPRO SURGIPRO SUTURE GAS COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death