BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 12352222 · Received August 23, 2021

    Report

    Report Number
    3002808486-2021-01748
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    June 10, 2021
    Report Date
    October 7, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ONCE THE DOCTOR DEPLOYED THE FILTER AND WAS RETRACTING THE DELIVERY SHEATH, IT SEEMED AS IF THE SHEATH AND FILTER WERE STILL CONNECTED. AS THE DOCTOR WAS PULLING THE SHEATH BACK, THE FILTER WAS MOVING IN THE DIRECTION OF THE SHEATH. THE DOCTOR PULLED ON THE SHEATH A FEW TIMES AND THE FILTER WAS PULLING IN UNISON. THEN THE DOCTOR ADVANCED THE SHEATH AND CATHETER BEYOND THE APEX OF THE FILTER AND THEN TRIED TO RETRACT. AT THAT POINT, THE SHEATH AND CATHETER WITHDREW WITHOUT CONNECTION TO THE FILTER. THE FILTER WAS ULTIMATELY PLACED WHERE IT WAS INTENDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. 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. 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 THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION AN EXACT CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. HOWEVER, EXCESSIVE TENSION DURING DEPLOYMENT MAY HAVE PREVENTED THE FILTER FROM BEING RELEASED. COOK MEDICAL WILL CONTINUE TO 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

    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). INITIAL MDR WAS SUBMITTED BY COOK INC UNDER MANUFACTURER REPORT REFERENCE# 1820334-2021-01798. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY WILLIAM COOK EUROPE. WITH THE SUBMISSION OF THIS INITIAL REPORT, WILLIAM COOK EUROPE INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED BY WILLIAM COOK EUROPE. LEAD TECH, PMA/510(K): K172557. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORTER: ON (B)(6) 2021: ONCE THE DOCTOR DEPLOYED THE FILTER AND WAS RETRACTING THE DELIVERY SHEATH, IT SEEMED AS IF THE SHEATH AND FILTER WERE STILL CONNECTED. AS HE WAS PULLING THE SHEATH BACK, THE FILTER WAS MOVING IN THE DIRECTION OF THE SHEATH. THE DOCTOR PULLED ON THE SHEATH A FEW TIMES AND THE FILTER WAS PULLING IN UNISON. HE THEN ADVANCED THE SHEATH AND CATHETER BEYOND THE APEX OF THE STENT AND THEN TRIED TO RETRACT. AT THAT POINT, THE SHEATH AND CATHETER WITHDREW WITHOUT CONNECTION TO THE FILTER. THE FILTER WAS ULTIMATELY PLACED WHERE IT WAS INTENDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249911 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR