BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 10975011 · Received December 9, 2020

    Report

    Report Number
    3002808486-2020-01130
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 26, 2020
    Report Date
    February 24, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER THE FILTER WAS RELEASED FROM A JUGULAR APPROACH THE DOCTOR WAS UNABLE TO REMOVE THE JUGULAR FILTER INTRODUCER. AFTER SEVERAL ATTEMPT TO REMOVE THE INTRODUCER THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE HAS BEEN REPORTED. A VIDEO OF FLUOROSCOPY AND DSA VENOGRAM WAS PROVIDED FOR THE INVESTIGATION AND AN IMAGING REVIEW WAS PERFORMED. PER IMAGING REVIEWER´S FINDINGS, ¿THE VIDEO RECORDING FROM TIME OF IVC FILTER PLACEMENT INCLUDING A DSA VENOGRAM OF THE IVC DEMONSTRATES NORMAL IVC ANATOMY. THE IVC MEASURES APPROXIMATELY 19 MM IN DIAMETER IN THE INFRARENAL LOCATION. A CELECT PLATINUM IVC FILTER WAS DEPLOYED IN THE INFRARENAL LOCATION. AFTER THE FILTER WAS COMPLETELY UNSHEATHED FROM THE DEPLOYMENT SYSTEM. THE RELEASE BUTTON WAS FIRED AND THE IVC FILTER WAS RELEASED FROM THE GRASPING HOOK OF THE DEPLOYMENT SYSTEM. HOWEVER, THERE ARE SEVERAL MINUTES OF FLUOROSCOPY WHERE THE OPERATOR IS ATTEMPTING TO REMOVE THE DEPLOYMENT SHEATH UNSUCCESSFULLY. EACH TIME THE DEPLOYMENT SHEATH IS RETRACTED, MOVEMENT OF THE IVC FILTER IS NOTED, ALTHOUGH THERE IS NO DIRECT CONNECTION BETWEEN THE DEPLOYMENT SHEATH AND THE IVC FILTER. EVENTUALLY THE SHEATH IS ADVANCED OVER THE GRASPING HOOK FREEING THE DEPLOYMENT DEVICE ENTIRELY WHICH IS THEN REMOVED UNEVENTFULLY.¿ PER IMAGING REVIEWER´S IMPRESSION,¿ THE IFU DOES DESCRIBE SLIGHT BACK TENSION SHOULD BE APPLIED TO THE DEPLOYMENT SYSTEM AT TIME OF RELEASING THE IVC FILTER. THIS MAY DECREASE THE LIKELIHOOD OF THE GRASPING HOOK ENGAGING WITH THE WALL OF THE IVC, ALTHOUGH THIS IS UNCERTAIN.¿ IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, 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. ACCORDING TO THE INSTRUCTION FOR USE EXCESSIVE TENSION DURING DEPLOYMENT MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION AN EXACT CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. A POSSIBILITY IS THAT EXCESSIVE TENSION DURING DEPLOYMENT PREVENTED THE GRASPING HOOK FROM BEING ADVANCED BACK INSIDE THE SHEATH. 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

    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#: (B)(4). SIMILAR TO DEVICE UNDER 510(K)/PMA: K171712. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: INSTALLATION OF THE FILTER WAS CONDUCTED WITHOUT ANY PROBLEMS. A PROBLEM OCCURRED WHILE REMOVING THE REMAINING PRODUCTS AFTER INSTALLING THE FILTER. AFTER SEVERAL ATTEMPTS, THE PROCEDURE ENDED WITHOUT ANY PROBLEMS. AFTER DETACHING THE PRODUCT, THE DOCTOR TRIED TO REMOVE THE FILTER CATHETER, BUT COULD NOT. THE DOCTOR FELT THAT THE FILTER AND THE CATHETER WERE CONNECTED. EVENTUALLY, THE SHEATH CAME DOWN, COVERED THE CATHETER, AND WAS FORCIBLY LIFTED UP AND REMOVED. 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
    1444311 COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3972323 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1