BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 16928818 · Received May 15, 2023

    Report

    Report Number
    3002808486-2023-00144
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 15, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K) K211875. SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER WAS RELEASED INSIDE THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. JUGULAR INTRODUCER, FEMORAL INTRODUCER, PRE-DILATOR, AND THE COAXIAL INTRODUCER SYSTEM WERE RETURNED FOR DEVICE EVALUATION. NO BLOOD OR BIOLOGICAL MATTER WERE PRESENT ON THE DEVICE. THERE WERE NO NONCONFORMANCES PRESENT ON THE PRE-DILATOR, JUGULAR INTRODUCER, OR THE COAXIAL INTRODUCER SYSTEM. THE RED SAFETY BUTTON ON THE FEMORAL INTRODUCER HAD BEEN PRESSED DOWN AND THERE WERE SOME FRAYS AND INDENTATIONS OBSERVED ON THE PISTON. THE CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED, BASED ON THE DEVICE EVALUATION. THE DAMAGE ON THE PISTON COULD BE FROM THE ANCHORS ON THE FILTER, IF THE FILTER WERE RELEASED WITHOUT PRESSING THE BLUE RELEASE BUTTON. IT IS UNKNOWN WHY THERE WAS NO BLOOD OR BIOLOGICAL MATTER PRESENT ON THE RETURNED PARTS SINCE THE FILTER WAS RELEASED INSIDE THE PATIENT AND WHY THE FILTER WAS NOT RETURNED. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, 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. THE IFU WARNS THAT EXCESSIVE FORCE SHOULD NOT BE USED TO ADVANCE THE FILTER THROUGH THE INTRODUCER SYSTEM. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION AND DEVICE EVALUATION AN EXACT CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. HOWEVER SINCE THE FILTER WAS NOT RETURNED AND THE RETURNED INTRODUCER SHEATH WAS WITHOUT ANY INDICATION THAT THE FILTER HAD BEEN RELEASED INSIDE THE SHEATH IT COULD INDICATE THAT THE FILTER WAS PRE-RELEASED BEFORE INSERTING THE FEMORAL INTRODUCER IN THE PATIENT BUT THIS IS PURELY SPECULATIONS. 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: FOUND ONE CELECT FILTER DEFECTIVE. PHYSICIAN COMPLETED WITH A FRESH ONE. THE FILTER WAS UNABLE TO COME OUT OF THE SHEATH INSIDE THE BODY. IT WAS RELEASED IN THE SHEATH NOT IN THE PATIENT. THIS WAS A FEMORAL PROCEDURE. PATIENT OUTCOME: ANOTHER FILTER USED AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031927 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4215167 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown