BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 14753447 · Received June 21, 2022

    Report

    Report Number
    3002808486-2022-00848
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    May 20, 2022
    Report Date
    July 26, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER ADVANCING THE JUGULAR INTRODUCER WITH FILTER THROUGH THE SHEATH, THE SHEATH COULD NOT BE WITHDRAWN TO DEPLOY THE FILTER. THE DEVICES WERE REMOVED AND REPLACED WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE COAXIAL INTRODUCER SYSTEM AND THE JUGULAR INTRODUCER WITH LOADED FILTER WERE RETURNED. ON THE JUGULAR INTRODUCER THE RED SAFETY BUTTON WAS PRESSED DOWN, IE THE SYSTEM WAS UNLOCKED AND THE PROTECTION SHEATH WAS KINKED 55MM FROM THE MOST DISTAL TIP. DURING INVESTIGATION THE JUGULAR INTRODUCER WITH THE FILTER WAS ADVANCED THROUGH THE SHEATH AND WHEN READY FOR FILTER DEPLOYMENT, THE SHEATH WAS WITHDRAWN WITHOUT RESISTANCE AND THE FILTER RELEASED WITHOUT DIFFICULTIES. BASED ON THESE FINDINGS AND THE INFORMATION PROVIDED THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE SPECIFY IN DETAIL HOW TO ADVANCE THE FILTER WITH THE FILTER INTRODUCER INTO THE INTRODUCER SHEATH AND FOLLOWING HOW TO CONNECT THE COMPONENTS TO POSITION THE FILTER AT THE RADIOPAQUE BAND OF THE INTRODUCER SHEATH BEFORE THE SHEATH IS WITHDRAWN AND THE FILTER IS RELEASED. ALSO, THE IFU WARN NOT TO ROTATE THE PRELOADED FILTER INSIDE THE INTRODUCER SYSTEM. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. 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 INTERNAL JUGULAR VEIN. AFTER THE FILTER CATHETER WAS INSERTED INTO THE SHEATH AND THESE TWO WERE CONNECTED, THE PHYSICIAN ATTEMPTED TO DEPLOY THE FILTER BY WITHDRAWING THE SHEATH. HOWEVER, THE SHEATH COULD NOT BE WITHDRAWN, SO THE FILTER COULD NOT BE DEPLOYED CONSEQUENTLY. THEREFORE, THE WHOLE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND ANOTHER IGTCFS-65-1-JUG-TULIP (LOT: E4188973) WAS USED INSTEAD TO COMPLETE THE PROCEDURE. 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
    189467 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52916 E4168274 10827002529165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown