BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 9005571 · Received September 12, 2019

    Report

    Report Number
    3002808486-2019-01465
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 20, 2019
    Report Date
    July 14, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G5) PMA/510(K) K171712. SUMMARY OF INVESTIGATIONAL FINDINGS: AS REPORTED THE PROCEDURE WAS A FILTER PLACEMENT WITH LEFT INTERNAL JUGULAR APPROACH. WHEN INSERTING THE FILTER, THE FILTER LEGS PUNCTURED THROUGH THE DELIVERY SHEATH. THE PHYSICIAN THEN REMOVED THE DELIVERY SHEATH AND OBSERVED A HOLE IN THE SHEATH (B)(4). THE PHYSICIAN TRIED AGAIN WITH ANOTHER FILTER KIT AND HAD TROUBLE ADVANCING THAT ONE ALSO (B)(4). PER DM SUGGESTION, CUSTOMER INSERTED A COOK 10FR PEELAWAY SHEATH TO STRAIGHTEN THE CHANNEL AND SUCCESSFULLY DEPLOYED THE FILTER. THE PHYSICIAN REPORTED THAT THE PATIENT ANATOMY WAS "SOMEWHAT TORTUOUS". THE PATIENT WAS NOT HARMED. REVIEW OF DEVICE HISTORY RECORD SHOWED NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. ACCORDING TO INSTRUCTION FOR USE EXCESSIVE FORCE SHOULD NOT BE EXERTED TO ADVANCE THE FILTER THROUGH THE DELIVERY SYSTEM. BASED ON THE PROVIDED INFORMATION A LIKELY CAUSE IS THAT PATIENT ANATOMY WAS TOO TORTUOUS AND CAUSED THE ADVANCEMENT TROUBLE. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# PR275268. PMA/510(K) K171712. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "PROCEDURE WAS A FILTER PLACEMENT WITH LEFT INTERNAL JUGULAR APPROACH; A NON-COOK TRIPLE LUMEN CATHETER WAS ALSO PRESENT FOR ALL OF THIS PROCEDURE--CUSTOMER AND DISTRICT MANAGER (DM) HAVE NOT ALLEGED OR EXPRESSED THAT THIS TRIPLE LUMEN CATHETER AFFECTED THE SUCCESS OF THIS PROCEDURE. PHYSICIAN SUCCESSFULLY GOT PRIOR ITEMS, INCLUDING DELIVERY SHEATH, THROUGH, PERFORMED VENOGRAM, AND TOOK OUT THE INNER DILATOR. WHEN INSERTING 1ST FILTER, THE FILTER LEGS PUNCTURED THROUGH THE DELIVERY SHEATH (PR275259). AT THIS POINT THE PHYSICIAN REMOVED THE FILTER, PUT WIRE DOWN, REMOVED DELIVERY SHEATH AND OBSERVED THE HOLE IN THE SHEATH. PHYSICIAN TRIED AGAIN WITH ANOTHER FILTER KIT AND HAD TROUBLE ADVANCING THAT ONE ALSO (PR275268). PER DM SUGGESTION, CUSTOMER INSERTED A COOK 10FR PEEL AWAY SHEATH TO STRAIGHTEN THE CHANNEL; AT THIS POINT THEY REINSERTED THE 2ND DELIVERY SHEATH AND ADVANCED THE FILTER SUCCESSFULLY." 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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800038 COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E3743825 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1