BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 14345048 · Received May 10, 2022

    Report

    Report Number
    3002808486-2022-00306
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 27, 2022
    Report Date
    June 9, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). OCCUPATION: INVENTORY MANAGER. PMA/510(K) K211875. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT NEITHER RIGHT NOR LEFT INTERNAL JUGULAR (IJ) ACCESS COULD BE PERFORMED DUE TO PRIOR CERVICAL SPINE ACCIDENT SO THE ACCESS SITE TO PLACE THE JUGULAR FILTER WAS AT CUBITAL. THE FILTER INTRODUCER WAS NOT ABLE TO MAKE THE BEND COMING DOWN FROM THE SUBCLAVIAN TO THE INFERIOR VENA CAVA (IVC) THROUGH THE INTRODUCER SHEATH (B)(4). ANOTHER DEVICE FROM A DIFFERENT LOT WAS TRIED BUT THE SAME THING HAPPENED AGAIN, THE FILTER INTRODUCER WAS NOT ABLE TO MAKE THE BEND. A COMPETITOR¿S DEVICE WAS USED INSTEAD AND COMPLETED THE PROCEDURE SUCCESSFULLY (B)(4). IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, 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. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO IMAGES WERE PROVIDED. BASED ON THE PROVIDED INFORMATION AN EXACT CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. HOWEVER, IT IS NOTED THAT THE DEVICE WAS PLACED VIA CUBITAL INSERTION. ACCORDING TO THE IFU ATTACHED THE PRODUCT IS INTENDED FOR PERCUTANEOUS PLACEMENT VIA A JUGULAR VEIN FOR FILTRATION OF INFERIOR VENA CAVA (IVC) BLOOD TO PREVENT PULMONARY EMBOLISM (PE). 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ACCESS SITE TO PLACE THE JUGULAR FILTER WAS AT ATICUBICAL AND WAS NOT ABLE TO MAKE THE BEND COMING DOWN FROM THE SUBCLAVIAN TO THE IVC (THROUGH THE INTRODUCER SHEATH). SHEATH WENT JUST FINE. SAME PROBLEM OCCURRED WITH BOTH DEVICES DURING THE SAME PROCEDURE. THEY WERE ABLE TO ACHIEVE PLACEMENT WITH AN IVC FILTER FROM ANOTHER MANUFACTURER. NEITHER RIGHT NOR LEFT INTERNAL JUGULAR ACCESS COULD BE PERFORMED DUE TO PRIOR CERVICAL SPINE ACCIDENT; PATIENT HAD CLOTS IN FEMORAL VEIN SO ACCESS COULDN'T BE DONE THERE. 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.

    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
    1552270 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4221719 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown