BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 6921505 · Received October 6, 2017

    Report

    Report Number
    3002808486-2017-01924
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    July 25, 2017
    Report Date
    January 4, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    PMA / PMN Number
    K121629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG# IGTCFS-65-1-JUG-CELECT-PT. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). H11: CORRECTED DATA COMPARED TO MEDWATCH REPORT (B)(4): B2) OTHER SERIOUS, B4) 17AUG2017, D1) CELECT PLATINUM, D2) FILTER, INTRAVASCULAR, CARDIOVASCULAR, D3) COOK INC., D4) CATALOG#: G34309, D10) YES, F6) MORE THAN 10 DAYS AGO, F9) 1 DAYS, F14 COOK INC. 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 MEDWATCH REPORT: "THE INFERIOR VENA CAVA (IVC) FILTER DEVICE WAS NOT ABLE TO RELEASE FROM DELIVERY SYSTEM BY OPERATOR: LIDOCAINE 1% WAS INFUSED FOR LOCAL ANESTHESIA. RIGHT INTERNAL JUGULAR VEIN WAS PATENT BY REAL-TIME SONOGRAPHY. MICROPUNCTURE TECHNIQUE WAS USED TO ACCESS THE RIGHT INTERNAL JUGULAR VEIN. THE CELECT SHEATH WAS ADVANCED INTO THE RIGHT COMMON ILIAC VEIN, AND IVC GRAM WAS PERFORMED, REVEALING NO EVIDENCE FOR THROMBUS IN THE IMAGED IVC. UNDER FLUOROSCOPIC GUIDANCE THE FILTER WAS DEPLOYED. INITIALLY, THERE WAS DIFFICULTY DEPLOYING THE FILTER: AFTER THE SAFETY BUTTON WAS PRESSED, THE SECOND DEPLOYMENT MECHANISM DID NOT WORK INITIALLY. WE ATTEMPTED TO RE-SHEATH THE FILTER, BUT THIS WAS ALSO NOT SUCCESSFUL. EVENTUALLY, THE MECHANISM DID DETACH, AND THE FILTER WAS DEPLOYED IN THE INFRA-RENAL LOCATION, IN THE EXACT LOCATION THAT WE INTENDED TO DEPLOY THE FILTER. AFTERWARDS WE DID NOT OBTAIN AN IVC GRAM, AS THE SHEATH WAS NOT FUNCTIONAL." PATIENT OUTCOME: UNKNOWN.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON EVENT DESCRIPTION AND RETURNED DEVICE. EXCEPT FROM THE FILTER THE COMPLETE DEVICE WAS RETURNED. THE JUGULAR INTRODUCER WAS PLACED INSIDE THE BLUE SHEATH AND BOTH WERE KINKED CLOSE TO THE SHEATH HANDLE. THE INTRODUCER WAS LOCKED IN HARDENED BLOOD AND CONSEQUENTLY THE RELEASE MECHANISM DID NOT WORK. TO REMOVE AND INVESTIGATE THE GRASPING HOOK ITSELF THE INTRODUCER WAS CUT AND THE HOOK WAS FOUND IN NORMAL SHAPE AND WITHOUT ANY DAMAGE, THUS INDICATING THAT THE INTRODUCER/HOOK HAD WORKED AS INTENDED. BASED ON THESE FINDINGS THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED WHEN ATTEMPTING TO RELEASE THE FILTER CANNOT BE DETERMINED, BUT REFERENCE IS MADE TO THE IFU, WARNING THAT EXCESSIVE TENSION DURING DEPLOYMENT MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED. IT IS NOTED THAT THE FILTER WAS DEPLOYED IN INTENDED LOCATION. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT IT DID NOT PERFORM AS INTENDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702427 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR