BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 2021958 · Received March 17, 2011

    Report

    Report Number
    9610978-2011-00054
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED SATES THAT DURING THE IMPLANTATION PROCEDURE THE OPTEASE RETRIEVABLE IVC FILTER HAD DEPLOYMENT DIFFICULTY. TO DATE NO ADDITIONAL DETAILS HAVE BEEN PROVIDED. THE INDICATION FOR THE FILTER INSERTION WAS DVT. THE VESSEL WAS NOT TORTUOUS. THERE WAS NO DIFFICULTY OR RESISTANCE/FRICTION WHILE ADVANCING THE DEPLOYMENT SHEATH TO THE DEPLOYMENT TARGET. ONE NON STERILE 6FR VESSEL DILATOR, ONE NON STERILE SHEATH INTRODUCER, ONE NON STERILE OBTURATOR AND A FILTER INSIDE ITS CARTRIDGE WERE RECEIVED INSIDE A PLASTIC BAG. NO VISUAL ANOMALIES WERE FOUND ON THE RETURNED UNITS. THE FILTER WAS DEPLOYED WITHOUT ANOMALIES. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED DURING ANALYSIS SINCE NO ANOMALIES WERE FOUND. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME SINCE NO ANOMALIES WERE FOUND. THE COMPLAINT OF DEPLOYMENT DIFFICULTY WAS NOT CONFIRMED ON ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE LIMITED INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING THE INTERVENTIONAL PROCEDURE THE OPTEASE RETRIEVAL FILTER HAD DEPLOYMENT DIFFICULTY. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. NA 15223026

    Patients

    Seq Age Sex Outcome Treatment
    1