BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 19916883 · Received August 6, 2024

    Report

    Report Number
    3002808486-2024-00148
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 10, 2024
    Report Date
    October 8, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) PMA/510(K): K233680. 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: APPROACH WAS DONE BY THE LEFT JUGULAR VEIN. THE ANATOMY WAS SUCH THAT THEY HAD TO MAKE A 90 DEGREE TURN TO ACCESS THE SUPERIOR VENA CAVA AND IT WAS DIFFICULT TRAVERSING THE RIGHT ANGLE TURN. THE INTRODUCER SHEATH BROKE IN THE PATIENT AND THE BROKEN PART WAS RETRIEVED WITH A BALLOON CATHETER. ANOTHER FILTER SET WAS USED AND THE FILTER PLACEMENT WAS SUCCESSFUL. NO ADVERSE EVENT TO THE PATIENT WAS REPORTED. AN INTRODUCER SHEATH AND A NON-COOK BALLOON WAS RETURNED AND EVALUATED. THE INTRODUCER SHEATH WAS FRACTURED IN TWO PARTS, WHICH WAS SEVERELY DEFORMED NEAR THE FRACTURE. THE PROXIMAL PART OF THE INTRODUCER SHEATH (ATTACHED TO THE HUB) HAD A KINK AND WAS NARROWED AND FOLDED NEAR THE FRACTURE. THE DISTAL PART OF THE INTRODUCER SHEATH (WITH THE TIP) HAD A TEAR AND WAS WIDENED. THIS COULD BE A RESULT OF THE INTRODUCER SHEATH GETTING STUCK IN THE 90 DEGREE ANGLE, RESULTING IN A SEVERE KINK, WHICH MAY HAVE LED TO TWISTING AND PULLING OF THE SHEATH. FURTHERMORE, THE TIP HAD AN INDENTATION, WHICH IS MOST LIKELY A RESULT OF EXCESSIVE FORCE. IT IS LIKELY THAT TORTUROUS ANATOMY COULD HAVE LED TO DIFFICULT ADVANCEMENT RESULTING IN EXCESSIVE FORCE EXERTED WHILE ADVANCING THE INTRODUCER SHEATH FOLLOWED BY THE FILTER INTRODUCER WITH THE FILTER THROUGH THE INTRODUCER SHEATH. THE IFU WARNS THAT IF SEVERE RESISTANCE IS MET WHEN ADVANCING THE WIRE GUIDE OR THE INTRODUCER SYSTEM, THEN THE USER MUST RETRACT AND CHOOSE A DIFFERENT APPROACH. EXCESSIVE FORCE SHOULD NOT BE EXERTED. FURTHERMORE, IFU STATES THAT FOR JUGULAR FILTER PLACEMENT, THE RIGHT JUGULAR VEIN IS USUALLY PREFERRED DUE TO ITS STRAIGHTER ROUTE TO THE VENA CAVA. AN APPROACH VIA THE LEFT JUGULAR VEIN MAY BE POSSIBLE, DEPENDING ON THE PATIENTS SIZE AND ANATOMY. IT IS UNKNOWN WHY APPROACH WAS MADE BY THE LEFT JUGULAR VEIN. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED 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 SHEATH OF THE FILTER SHEATH BROKE INTO COMING FROM THE LEFT INTERNAL JUGULAR AT AN ACUTE ANGLE, BROKE INTO AND RETRIEVED WITH A BALLOON CATHETER. THEY USED ANOTHER UNI-CELECT IVC FILTER AND THEY WERE SUCCESSFUL. THERE WAS NO PATIENT COMPLICATION.

    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
    1635539 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34505 E4557635 10827002345055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention