BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 18532538 · Received January 18, 2024

    Report

    Report Number
    3002808486-2024-00009
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 10, 2024
    Report Date
    March 12, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K211875. 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: THE CELECT-PT FILTER HOOK STRAIGHTENED DURING A SECOND RETRIEVAL ATTEMPT MORE THAN TWO YEARS AFTER FILTER PLACEMENT. THE FILTER WAS SUCCESSFULLY RETRIEVED BY ALTERNATIVE RETRIEVAL TECHNIQUE WITHOUT REPORTED HARM TO THE PATIENT. THE CELECT-PT FILTER WAS NOT RETURNED AND THE RETRIEVAL DEVICE IS UNKNOWN. THEREFORE, BASED ON THE INFORMATION PROVIDED ONLY IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE HOOK TO STRAIGHTEN DURING A RETRIEVAL ATTEMPT MORE THAN TWO YEARS AFTER FILTER PLACEMENT. HOWEVER, REPORTEDLY THE STRAIGHTENED HOOK WAS DUE TO ¿THE FORCE THEY WERE PULLING THE SHEATH BACK WITH¿, AND IF RETRIEVED BY THE GÜNTHER TULIP® VENA CAVA FILTER RETRIEVAL SET (GTRS-200-RB) IT IS ASSUMED THAT ATTEMPTS WERE MADE TO RETRIEVE THE FILTER WITHOUT COLLAPSING IT BY ADVANCING THE SHEATH. THE CELECT-PT FILTER IS DESIGNED TO BE RETRIEVED WITH THE GTRS-200-RB AND THE INSTRUCTIONS FOR USE SUPPLIED WITH THE RETRIEVAL DEVICE INSTRUCT TO ADVANCE THE RETRIEVAL SHEATH TO COLLAPSE THE FILTER AND DISENGAGE THE FILTER ANCHORS FROM THE CAVAL WALL, BEFORE ADVANCING THE OUTER SHEATH TO COVER THE ENTIRE FILTER FOR RETRIEVAL. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. 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 HOOK OF THE FILTER STRAIGHTENED OUT DURING THE FIRST ATTEMPT OF RETRIEVAL OF IGTCFS-65-2-JUG-CELECT-PT, THE PHYSICIAN EXPLAINED THIS WAS DUE TO THE THE FORCE THEY WERE PULLING THE SHEATH BACK WITH DUE TO THE FILTER BEING EMBEDDED. COMPLAINT FACILITY TRIED TO REMOVE IVC FILTER WHICH HAD BEEN IMPLANTED IN 2021. THE FIRST ATTEMPT TO RETRIEVE IT WAS LATER IN 2021. THE FILTER WAS IN A STABLE POSITION AND THE HOOK WAS SNARED BUT THE HOOK STRAIGHTENED OUT AND SO THEY THEN HAD TO USE A SOS CATHETERS AND USE THE WIRE LOOP TECHNIQUE WITH A 16FR PERFORMER SHEATH TO REMOVE THE FILTER. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT 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
    818726 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention