BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 16852486 · Received May 2, 2023

    Report

    Report Number
    3002808486-2023-00129
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    March 22, 2023
    Report Date
    June 23, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) PMA/510(K): K211875. H11) CORRECTED DATA COMPARED WITH MEDWATCH REPORT MW5116045: D1) COOK CELECT PLATINUM VENA CAVA FILTER SET. D9) Y. H6 ANNEX E) 4580: INSUFFICIENT INFORMATION. H6 ANNEX A) 3270: ACTIVATION FAILURE. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4) SUMMARY OF INVESTIGATIONAL FINDINGS: THE IGTCFS-65-1-JUG-CELECT-PT FILTER (COMPLAINT DEVICE) WOULD NOT RELEASE FROM THE JUGULAR INTRODUCER, WHY RE-SHEATHED AND REMOVED. AFTER REMOVAL THE FILTER WOULD STILL NOT RELEASE, BUT WAS MANUALLY PULLED OFF THE TRIGGER WIRE. ASSUMING ANOTHER FILTER WAS SUCCESSFULLY PLACED, SINCE THE FAILED FILTER RELEASE CAUSED NO REPORTED HARM TO THE PATIENT. THE JUGULAR INTRODUCER ALONG WITH THE FILTER CELECT-PT WAS RETURNED. PER THE DEVICE EVALUATION ON THE JUGULAR INTRODUCER THE RED SAFETY BUTTON WAS PRESSED DOWN AND HAD A KINK 425MM FROM DISTAL END. THE OUTER PART/CANNULA OF THE JUGULAR INTRODUCER SUBASSEMBLY WAS BEND/FRACTURED. WHEN THE BLUE RELEASE BUTTON WAS PRESSED DOWN, THE GRASPING HOOK WOULD NOT COME OUT. THE BEND/FRACTURE OF THE OUTER PART/CANNULA WILL PREVENT THE GRASPING HOOK TO RELEASE THE FILTER. ON THE FILTER CELECT-PT NO NONCONFORMANCE WAS OBSERVED AT THE FILTER HOOK. BASED ON THE DEVICE EVALUATION THE CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED. AN INTERNAL ACTION HAS BEEN INITIATED TO ADDRESS THE DIFFICULTIES IN RELEASING THE FILTER FROM THE JUGULAR INTRODUCER AND IS STILL ONGOING. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, THERE IS EVIDENCE THAT THE DEVICE HISTORY RECORD 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 21CFR 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: THE PATIENT WAS UNDERGOING PLANNED PLACEMENT OF AN INFERIOR VENA CAVA (IVC) FILTER THROUGH JUGULAR VEIN. A J-WIRE WAS ADVANCED UNDER FLUORO AND ITS TRAJECTORY CONFIRMED TO BE IN THE IVC. THE DEVICE WAS PREPPED AND THE DEVICE SHEATH ADVANCED OVER WIRE INTO ABDOMINAL IVC. THE FILTER DEVICE WAS THEN ADVANCED OVERWIRE AND ATTEMPTED TO BE DEPLOYED HOWEVER DESPITE APPROPRIATE DEPLOYMENT SEQUENCE, THE FILTER DID NOT COME FREE OF THE DELIVERY SYSTEM. IT WAS THEREFORE RE-SHEATED AND WITHDRAWN. ON THE BACK TABLE IT WAS ATTEMPTED TO BE DEPLOYED BUT DID NOT COME FREE READILY AND HAD TO BE MANUALLY PULLED OFF THE TRIGGER WIRE. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160587 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4360246 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown