BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 7536074 · Received May 23, 2018

    Report

    Report Number
    3002808486-2018-00598
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    April 23, 2018
    Report Date
    August 9, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    PMA / PMN Number
    K121629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    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). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404, REGISTRATION NO.: 3005580113, H6) EC METHOD CODE: 4109 - HISTORICAL DATA ANALYSIS . SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON EVENT DESCRIPTION AND RETURNED DEVICE. THE JUGULAR INTRODUCER RETURNED WITH LOADED FILTER WITHDRAWN INTO THE PROTECTION SHEATH. THE RED LOCKING BUTTON WAS NOT PRESSED, IE THE SYSTEM WAS STILL LOCKED, BUT WHEN UNLOCKED THE DEVICE WORKED AS INTENDED AND THE FLTER COULD BE ADVANCED AND EXPANDED WITHOUT DIFFICULTIES. THEREFORE, BASED ON THE LIMITED INFORMATION PROVIDED IT WOULD BE INAPPROPRIATE TO SPECULATE ON WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER LEGS TO NOT EXPAND . HOWEVER, IT IS PREVIOUSLY SEEN THAT THE FILTER LEGS MAY BE SOMEHOW OBSTRUCTED FROM FULLY EXPANDING DUE TO E.G. IVC ANATOMICAL CONDITIONS, CLOTS OR IF THE FILTER IS NOT PLACED IN IVC. THE DEVICE WAS SUCCESSFULLY REMOVED AND REPLACED. IFU: STABILIZE THE INTRODUCER, AND WITHDRAW THE INTRODUCER SHEATH AND PROTECTION SHEATH UNTIL THE PROTECTION SHEATH AND HANDLE ARE CONNECTED. AT THIS POINT THE FILTER IS EXPANDED, STILL CONNECTED TO THE FILTER INTRODUCER. WHEN THE FILTER POSITION IS CORRECT, PUSH THE RED SAFETY BUTTON TO PREPARE FILTER RELEASE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT IT DID NOT PERFORM AS INTENDED DURING ATTEMPTED FILTER PLACEMENT. 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: "FILTER WOULD NOT FULLY "FLOWER" LEGS WERE STILL BOUND. NO ADVERSE EVENT TO PATIENT. OTHER PRODUCT USED: MICROPUNCTURE, ROSEN AND ANGLED GLIDE WIRE." "THEY TOOK IT OUT AND PUT A NEW FILTER IN AND DEPLOYED FINE." PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "FILTER WOULD NOT FULLY "FLOWER" LEGS WERE STILL BOUND. NO ADVERSE EVENT TO PATIENT. OTHER PRODUCT USED: MICROPUNCTURE, ROSEN AND ANGLED GLIDE WIRE." "THEY TOOK IT OUT AND PUT A NEW FILTER IN AND DEPLOYED FINE." PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378360 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E3581644 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR