BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 17359974 · Received July 20, 2023

    Report

    Report Number
    3002808486-2023-00204
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    May 3, 2023
    Report Date
    July 20, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G5) 510(K)# K211875. EVENT BECAME REPORTABLE AFTER INVESTIGATION. SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER WOULD NOT DETACH AND ANOTHER FILTER WOULD NOT EXPAND. A NON-COOK FILTER WAS PLACED WITH NO REPORTED HARM TO THE PATIENT. THE JUGULAR INTRODUCER AND THE CELECT-PT FILTER WERE RETURNED. ON THE JUGULAR INTRODUCER THE SAFETY BUTTON WAS PRESSED DOWN AND WHEN PRESSING THE RELEASE BUTTON, THE GRASPING HOOK INSIDE THE INTRODUCER MOVED FREELY. THE FILTER WAS NICELY SHAPED/EXPANDED AND FOUND ACCORDING TO SPECIFICATIONS. NO IMAGING COULD BE OBTAINED AND BASED ON THE INVESTIGATION FINDINGS ONLY, THE EXACT REASON WHY THE FILTER LEGS ¿WOULD NOT OPEN ALL THE WAY¿ CANNOT BE DETERMINED. HOWEVER, IT IS PREVIOUSLY SEEN THAT THE FILTER LEGS MAY BE SOMEHOW OBSTRUCTED FROM FULLY EXPANDING IF THE FILTER IS DEPLOYED IN A THROMBUS, OR THE FILTER LEGS ARE CAUGHT IN A CLOT, AND THE INSTRUCTIONS FOR USE LIST ¿FAILURE OF FILTER EXPANSION/INCOMPLETE EXPANSION¿ AS A POTENTIAL ADVERSE EVENT. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: LOT E4393441 WOULD NOT DETACH AND LOT E4391727 LEGS WOULD NOT OPEN ALL THE WAY. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: PHYSICIAN PLACED AN FILTER FROM ANOTHER MANUFACTURER. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839644 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4391727 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female