BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 16793931 · Received April 24, 2023

    Report

    Report Number
    3002808486-2023-00108
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    December 21, 2022
    Report Date
    April 24, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). PMA/510(K): K211875. SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER WOULD NOT DEPLOY BECAUSE THE HOOK WOULD NOT DISENGAGE FROM THE FILTER. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE SUCCESSFULLY. JUGULAR INTRODUCER AND THE FILTER WERE RETURNED FOR EVALUATION. BLOOD AND BIOLOGICAL MATTER WERE PRESENT ON THE DEVICE. FILTER WAS RETURNED INSIDE THE PROTECTION SHEATH OF THE JUGULAR INTRODUCER, THERE WERE NO NONCONFORMANCES OBSERVED ON THE FILTER. THE GRASPING HOOK ON THE JUGULAR INTRODUCER WAS COVERING THE HOOK OF THE FILTER, THERE WAS NO NONCONFORMANCES OBSERVED ON THE GRASPING HOOK. THE BLUE RELEASE BUTTON WAS VERY DIFFICULT TO PRESS AND WHEN THE BLUE RELEASE BUTTON WAS DEPRESSED IT WOULD NOT COME UP AGAIN I.E., THE GRASPING HOOK WAS STUCK OUT. THE HANDLE ON THE JUGULAR INTRODUCER WAS SEPARATED, THERE WAS NO INDICATION THAT THE RELEASE BUTTON HAS BEEN FORCED PRESSED BEFORE PUSHING THE RED SAFETY BUTTON AND NO NONCONFORMANCES WERE OBSERVED. A SMALL KINK NEAR THE WELDING AND BLOOD WERE OBSERVED ON THE GRASPING HOOK. THE CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED, BASED ON THE DEVICE EVALUATION. THE OBSERVATION WITH THE BLUE RELEASE BUTTON WAS PRESSED DOWN AND COULD NOT COME UP AGAIN I.E., THE GRASPING HOOK ON THE JUGULAR INTRODUCER WAS STUCK OUT, LED TO RIC-2023-001 WAS INITIATED. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE FINAL INSPECTION, 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. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. 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 FILTER WOULD NOT DEPLOY BECAUSE THE HOOK WOULD NOT DISENGAGE FROM THE FILTER. ANOTHER FILTER WAS GRABBED OFF THE SHELF (SAME ONE) AND COMPLETED SUCCESSFULLY. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701654 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4281965 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown