BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 17255114 · Received July 5, 2023

    Report

    Report Number
    3002808486-2023-00190
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    May 22, 2023
    Report Date
    September 25, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER 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 WOULD NOT RELEASE AFTER ADJUSTING, THUS ASSUMING ATTEMPT WAS MADE TO PLACE THE FILTER FROM JUGULAR APPROACH. THE DEVICE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FILTER WITHOUT ANY HARM TO THE PATIENT. THE COAXIAL INTRODUCER SHEATH SYSTEM AND THE CELECT-PT FILTER WERE RETURNED WITH FEMORAL AND JUGULAR INTRODUCERS. EXCEPT FROM A KINKED SECONDARY FILTER, ANY COMPONENT WAS FOUND MANUFACTURED ACCORDING TO SPECIFICATIONS AND THE FILTER COULD BE ATTACHED TO THE JUGULAR INTRODUCER AND RELEASED WITHOUT DIFFICULTIES. THEREFORE, BASED ON THESE FINDINGS THE EXACT REASON, WHY THE FILTER WOULD NOT RELEASE FROM THE JUGULAR INTRODUCER AFTER REPOSITIONING CANNOT BE DETERMINED. HOWEVER, APPROPRIATE ACTION HAS PREVIOUSLY BEEN INITIATED AND RELEVANT PERSONNEL HAVE BEEN NOTIFIED TO ADDRESS DIFFICULTIES IN RELEASING THE FILTER FROM THE JUGULAR INTRODUCER AND IS STILL ONGOING. ALSO, THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE SPECIFY HOW TO RELOAD THE FILTER FROM FEMORAL TO JUGULAR INTRODUCER, WARN NOT TO ROTATE THE PRELOADED FILTER INSIDE THE INTRODUCER SYSTEM, AND 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 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: DURING THE PROCEDURE OF IMPLANTATION OF VENA CAVA FILTER, ADVANCED THE DELIVERY SHEATH AND DILATOR ALONG THE WIRE GUIDE TO THE LOWER POSITION OF RENAL VEIN. THEN THE WIRE GUIDE WAS REMOVED, VENA CAVA ANGIOGRAPHY WAS PERFORMED, THEN THE DILATOR WAS REMOVED, THE POSITION OF THE FILTER WAS CONFIRMED, AND THE DELIVERY SHEATH WAS WITHDRAWN TO THE INTERFACE WITH THE CONTROL HANDLE SO THAT THE FILTER WAS EXPOSED FROM THE SHEATH. PUT THE FILTER INTO THE DELIVERY SHEATH, ADJUST THE POSITION, THE FILTER CAN NOT BE RELEASED IN THE SHEATH. REPLACE ANOTHER FILTER AND RELEASE SUCCESSFULLY. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR ADVERSE EFFECTS 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
    418685 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4358841

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female