BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

    MDR report key: 10708425 · Received October 20, 2020

    Report

    Report Number
    1820334-2020-01909
    Event Type
    Injury
    Date Received
    October 20, 2020
    Report Date
    December 17, 2020
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. DESCRIPTION OF EVENT: AS REPORTED BY THE PATIENT, AN UNKNOWN COOK INFERIOR VENA CAVA FILTER PUNCTURED THE PATIENT'S AORTA. THE FILTER WAS PLACED EMERGENTLY IN 2006 IN FLINT, MICHIGAN. AN MRI WAS PERFORMED AT AN AFFILIATED FACILITY, ON AN UNKNOWN DATE, FINDING THAT THE DEVICE HAD PUNCTURED THE AORTA. THE PATIENT HAS RECEIVED TWO UNITS OF BLOOD AND REPORTEDLY MAY REQUIRE ADDITIONAL TRANSFUSIONS. INVESTIGATION ¿ EVALUATION. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL DATA. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS MADE OUT OF SPECIFICATION. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: POTENTIAL ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO: FILTER MIGRATION (MAY OCCUR IF PROPER ANCHORING TECHNIQUES ARE NOT UTILIZED). INFERIOR VENA CAVA THROMBOSIS. PERFORATION OF VENA CAVA WALL. HEMATOMA AT PUNCTURE SITE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE INVESTIGATION CONCLUSION COULD NOT ESTABLISH A POSSIBLE CAUSE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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

    NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    REPORTER OCCUPATION = PATIENT. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT, AN UNKNOWN COOK INFERIOR VENA CAVA FILTER PUNCTURED THE PATIENT'S AORTA. THE FILTER WAS PLACED EMERGENTLY IN 2006 IN FLINT, MICHIGAN. AN MRI WAS PERFORMED AT AN AFFILIATED FACILITY, ON AN UNKNOWN DATE, FINDING THAT THE DEVICE HAD PUNCTURED THE AORTA. THE PATIENT HAS RECEIVED TWO UNITS OF BLOOD AND REPORTEDLY MAY REQUIRE ADDITIONAL TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172227 DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R