BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 10688499 · Received October 16, 2020

    Report

    Report Number
    3002808486-2020-00952
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    October 7, 2020
    Report Date
    February 11, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE DEPLOYED IVC FILTER AND DEPLOYMENT SYSTEM APPEARED TO BE CONNECTED AFTER DEPLOYMENT. THEY PUSHED THE BLUE BUTTONS SEVERAL TIMES AND IT FINALLY LET GO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. JUGULAR INTRODUCER AND INTRODUCER SHEATH WERE RETURNED FOR PRODUCT EVALUATION. PER PRODUCT EVALUATION: IT WAS POSSIBLE EVEN WITH A LOT OF HARDEN BLOOD TO ADVANCE THE GRASPING HOOK BY PUSHING THE BLUE RELEASE BUTTON. NO NONCONFORMANCE AT THE GRASPING HOOK. NO NONCONFORMANCE OBSERVED AT THE PRODUCT AND IT IS NOT POSSIBLE TO DETERMINE THE REPORTED FAILURE, BASED ON THE PRODUCT EVALUATION. BUT THE REPORTED FAILURE IS MOST LIKELY SEEN, IF THERE IS USED TO MUCH BACK TENSION DURING RELEASE, THIS MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, 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. HOWEVER, A LIKELY CAUSE IS THAT EXCESSIVE TENSION DURING DEPLOYMENT COULD CONTRIBUTE TO THE REPORTED EVENT. 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

    MANUFACTURERS REF# (B)(4). OCCUPATION: NON-HEALTHCARE PROFESSIONAL. 510(K)/PMA: K172557. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEPLOYED IVC FILTER AND DEPLOYMENT SYSTEM APPEARED TO BE CONNECTED AFTER DEPLOYMENT. THEY PUSHED THE BLUE BUTTONS SEVERAL TIMES AN IT FINALLY LET GO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. 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
    1158612 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52916 E3963263 10827002529165

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR