BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 15155232 · Received August 3, 2022

    Report

    Report Number
    3002808486-2022-00914
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 25, 2022
    Report Date
    October 27, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). 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

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER UNSHEATHED, THE FILTER WOULD NOT RELEASE, WHEN PRESSING THE RELEASE BUTTON. IT RELEASED WHEN HALF-WAY RE-SHEATHED, BUT NEEDED SHAKING TO GET OUT OF THE SHEATH. THE SHAKING CAUSED THE FILTER TO TILT, BUT IT WAS LEFT IN THE PATIENT WITHOUT ANY HARM REPORTED. NO DEVICE WAS RETURNED FOR ANALYSIS AND WITHOUT THE ACTUAL COMPLAINT DEVICE IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE DIFFICULTIES IN RELEASING THE FILTER FROM THE JUGULAR INTRODUCER. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE UNI DEVICE SPECIFY IN DETAIL HOW TO RELOAD THE FILTER FROM THE FEMORAL TO THE JUGULAR INTRODUCER AND HOW TO PROPERLY RELEASE THE FILTER BY PUSHING THE RELEASE BUTTON COMPLETELY. THE IFU ALSO NOTE THAT EXCESSIVE TENSION DURING DEPLOYMENT MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE 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.

    Description of Event or Problem · 0

    THE DOCTOR UNSHEATHED THE FILTER. HE PUSHED THE RED SAFETY BUTTON AND THEN PUSHED THE BLUE BUTTON, BUT THE FILTER WOULD NOT COME OFF THE DELIVERY SYSTEM. THE DOCTOR THEN RE-SHEATHED THE FILTER AND IT WAS HALF WAY RE-SHEATHED WHEN THE FILTER DID COME OFF THE DELIVERY SYSTEM. HE HAD TO SHAKE THE FILTER OUT OF THE SHEATH TO GET IT TO DEPLOY. THIS CAUSED A TILTED PLACEMENT. THEY DECIDED TO LEAVE IT IN PLACE. 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
    869828 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34505 E4250133 10827002345055

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male