BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 14943205 · Received July 7, 2022

    Report

    Report Number
    3002808486-2022-00880
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 23, 2022
    Report Date
    September 22, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K211874. INVESTIGATION IS STILL IN PROGRESS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# PR367863 SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER RE-SHEATHING THE FILTER THREE TIMES IT DETACHED FROM THE JUGULAR INTRODUCER WITHOUT PRESSING THE RELEASE BUTTON. THE FILTER WAS PLACED IN GOOD POSITION AND NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. BASED ON THE LIMITED INFORMATION PROVIDED IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER TO DETACH FROM THE JUGULAR INTRODUCER AFTER THREE ATTEMPTS OF REPOSITIONING. THE DEVICE WAS NOT RETURNED AND WITHOUT A PROPER ANALYSIS OF THE DEVICE COMPONENTS ANY SUGGESTION OF A CAUSE WOULD BE PURE SPECULATION. HOWEVER, IT IS PREVIOUSLY EXPERIENCED THAT THE FILTER MAY DETACH FROM THE JUGULAR INTRODUCER, IF THE SYSTEM IS UNLOCKED AND THE RELEASE BUTTON IS INADVERTENTLY PUSHED, OR THAT THE GRASPING HOOK STRAIGHTENS DURING ATTEMPTS TO REPOSITION THE FILTER, THUS SLIPPING THE FILTER HOOK. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE SPECIFY HOW TO VERIFY THE POSITION OF THE INTRODUCER SHEATH TIP BEFORE ADVANCING THE JUGULAR INTRODUCER WITH THE FILTER AND HOW TO ENSURE CORRECT PLACEMENT OF THE FILTER AT THE RADIOPAQUE BAND BEFORE WITHDRAWING THE SHEATH AND UNLOCKING THE SYSTEM FOR FILTER RELEASE. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE IS MANUFACTURED TO SPECIFICATIONS. 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. COOK MEDICAL WILL 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: APPROACH WAS GAINED FROM THE RIGHT JUGULAR VEIN. THE FILTER GOT RELEASED ALTHOUGH THE PHYSICIAN DID NOT PUSH THE RELEASE BUTTON. THE PLACED POSITION WAS GOOD DESPITE THE UNINTENDED RELEASE, THE FILTER WAS PLACED AS IT WAS. PHYSICIAN RE-SHEATHED THE FILTER THREE TIMES PRIOR TO THE EVENT PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    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
    1047025 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52916 E4191396 10827002529165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown