BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 16937424 · Received May 16, 2023

    Report

    Report Number
    3002808486-2023-00147
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    May 4, 2023
    Report Date
    July 19, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER COULD NOT BE RELEASED FROM THE JUGULAR INTRODUCER. THE SYSTEM WAS REMOVED AND A SECOND ATTEMPT WENT SMOOTHLY. THE INTRODUCER SHEATH, THE CELECT-PT FILTER, AND THE JUGULAR INTRODUCER WITH CATHETER WERE RETURNED. THE GRASPING HOOK STUCK INSIDE THE INTRODUCER AND THEREFORE THE HANDLE WAS OPENED. HOWEVER, NO NON-CONFORMANCES COULD BE FOUND AND THEREFORE, BASED ON THE INVESTIGATION FINDINGS THE EXACT REASON FOR THE STICKING INTRODUCER AND THE DIFFICULTIES IN RELEASING THE FILTER CANNOT BE DETERMINED, BUT RELEVANT PERSONNEL HAVE BEEN NOTIFIED AND APPROPRIATE ACTIONS HAVE BEEN TAKEN TO ADDRESS SAID ISSUES. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. 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. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). G4) PMA/510(K) K211875. INVESTIGATION IS STILL IN PROGRESS. 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN WENT TO DEPLOY A CELECT PLATINUM AND SAID IT WAS STUCK WHEN HE WENT TO DEPLOY, NO AMOUNT OF PRESSURE ON THE RELEASE BUTTON WOULD GET THE FILTER OUT OF THE SHEATH. HE SAID IT FELT JAMMED OR STUCK ALMOST. THEY REMOVED THE ENTIRE SYSTEM AND OPENED ANOTHER CELECT PLATINUM SET AND THE SECOND ATTEMPT WENT SMOOTHLY. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556057 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4354589 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 Male