BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 17441450 · Received August 2, 2023

    Report

    Report Number
    3002808486-2023-00213
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 13, 2023
    Report Date
    September 26, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) PMA/510(K): K211875. 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 FILTER DID NOT RELEASE FROM HOOK INITIALLY. THE MAL-DEPLOYED FILTER WAS RETRIEVED AND ANOTHER WAS PLACED. NO REPORTED HARM TO THE PATIENT. THE COAXIAL SHEATH SYSTEM AND THE JUGULAR INTRODUCER WERE RETURNED. WHEN PRESSING THE RELEASE BUTTON ON THE JUGULAR INTRODUCER THE HOOK DID NOT MOVE INSIDE DUE TO HARDENING BLOOD/CONTRAST, BUT A THOROUGH INVESTIGATION OF THE HANDLE AFTER OPENING IT DID NOT REVEAL ANY NONCONFORMANCE. THE CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED, BUT THE HARDENED BLOOD/CONTRACT OR USE OF EXCESSIVE BACK TENSION DURING RELEASE MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED. HOWEVER, RELEVANT PERSONNEL HAVE BEEN NOTIFIED AND INTERNAL ACTION HAS PREVIOUSLY BEEN INITIATED TO ADDRESS ANY DIFFICULTIES IN RELEASING THE FILTER FROM THE JUGULAR INTRODUCER. SAID ACTION IS STILL ONGOING. 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 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2023 - DIFFICULT DEPLOYMENT OF A CELECT PLATINUM FILTER. ADDITIONAL INFORMATION RECEIVED 28JUL2023: FILTER DIDN¿T DEPLOY FROM THE HOOK INITIALLY. PATIENT OUTCOME: THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE: THEY HAD TO RETRIEVE THE MAL-DEPLOYED FILTER AND PLACE ANOTHER.

    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

    ADDITIONAL INFORMATION RECEIVED ON 07AUG2023: THE BUTTONS WORKED FINE. THE PHYSICIAN SAID HE WASN¿T SURE WHAT WAS KEEPING IT FROM RELEASING FROM THE HOOK. THE PATIENT HAD NORMAL ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695268 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4290261 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Required Intervention