BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 10430013 · Received August 20, 2020

    Report

    Report Number
    3002808486-2020-00795
    Event Type
    Injury
    Date Received
    August 20, 2020
    Report Date
    September 8, 2020
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A2) UNKNOWN AS NOT PROVIDED BY REPORTER. A4) UNKNOWN AS NOT PROVIDED BY REPORTER. D1) UNKNOWN AS CATALOG NUMBER IS UNKNOWN. D4) LOT - UNKNOWN AS NOT PROVIDED BY REPORTER. CATALOG NUMBER - UNKNOWN AS NOT PROVIDED BY THE REPORTER. EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. F9) UNKNOWN AS NOT PROVIDED BY REPORTER. F10) PATIENT CODE: DAMAGE TO THE VENA CAVA IS LABELED IN THE IFU. PERFORATION IS NOT SPECIFICALLY LABELED IN THE IFU. DEVICE CODE - DIFFICULT TO REMOVE IS NOT LABELED IN THE IFU. G5) 510(K) NUMBER COULD BE K043509 OR K072240. EXACT NUMBER CANNOT BE KNOWN AS CATALOG NUMBER IS UNKNOWN. H4) UNKNOWN AS NOT PROVIDED BY REPORTER.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4). THIS REPORT WAS MISTAKENLY SUBMITTED AND IS A DUPLICATE OF REPORT UNDER MANUFACTURER REPORT # 3002808486-2015-00060. THIS REPORT IS CANCELLED AND ALL FUTURE INFORMATION WILL BE HANDLED UNDER MANUFACTURING REPORT# 3002808486-2015-00060. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    PER LAWSUIT FILED, IT IS ALLEGED A FEMALE PATIENT WITH RECURRENT DVT'S IN HER LEG UNDERWENT IVC FILTER PLACEMENT WITH A GÜNTHER TULIP FILTER ON (B)(6) 2008. THERE WERE NO REPORTED COMPLICATIONS AT THE TIME. THE ALLEGATIONS OF THE LAWSUIT ARE: ON OR ABOUT (B)(6) 2013, THE PATIENT PRESENTED TO THE HOSPITAL TO HAVE THE COOK GÜNTHER TULIP FILTER REMOVED. UNFORTUNATELY, THE ENTIRE FILTER WAS UNABLE TO BE REMOVED. UPON CLOSER EXAMINATION, IT WAS DISCOVERED THAT SEVERAL STRUTS OF THE FILTER HAD PERFORATED THE PATIENT'S VENA CAVA. PARTS OF THE COOK GÜNTHER TULIP FILTER REMAIN INSIDE THE PATIENT. AS OF JUNE 13, 2014 NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4). UNKNOWN AS NOT PROVIDED BY REPORTER. LOT#: E2107623. CATALOG#: IGTCFS-65-UNI-CELECT-PERM. EXPIRE DATE: 20DEC2009. UNKNOWN AS NOT PROVIDED BY REPORTER. PATIENT CODE: DAMAGE TO THE VENA CAVA IS LABELED IN THE IFU. PERFORATION IS NOT SPECIFICALLY LABELED IN THE IFU. DEVICE CODE: DIFFICULT TO REMOVE IS NOT LABELED IN THE IFU. MANUFACTURER REPORT # HAS CHANGED FROM 1820334-2014-00289 TO 3002808486-2015-00060 DUE TO ADDITIONAL INFORMATION ON LOT# RESULTING IN CHANGE OF MANUFACTURER FROM COOK INC. TO WILLIAM COOK EUROPE DEVICE MANUFACTURE DATE: 20DEC2007. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PER LAWSUIT FILED, IT IS ALLEGED. A FEMALE PATIENT WITH RECURRENT DVT'S IN HER LEG UNDERWENT IVC FILTER PLACEMENT WITH A GÜNTHER TULIP FILTER ON (B)(6) 2008. THERE WERE NO REPORTED COMPLICATIONS AT THE TIME. THE ALLEGATIONS OF THE LAWSUIT ARE: ON OR ABOUT (B)(6) 2013, THE PATIENT PRESENTED TO THE HOSPITAL TO HAVE THE COOK GÜNTHER TULIP FILTER REMOVED. UNFORTUNATELY, THE ENTIRE FILTER WAS UNABLE TO BE REMOVED. UPON CLOSER EXAMINATION, IT WAS DISCOVERED THAT SEVERAL STRUTS OF THE FILTER HAD PERFORATED THE PATIENT'S VENA CAVA. PARTS OF THE COOK GÜNTHER TULIP FILTER REMAIN INSIDE THE PATIENT. AS OF (B)(6) 2014 NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894702 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK E2107623

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening