BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 13792526 · Received March 17, 2022

    Report

    Report Number
    1820334-2022-00404
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Report Date
    April 6, 2022
    Manufacturer
    COOK INC
    Product Code
    MMX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K181757. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: B1, B5, H1: ADDITIONAL INFORMATION/CLARIFICATION WAS RECEIVED. THE COMPLAINT DEVICE WAS NOT A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, AS ORIGINALLY REPORTED, BUT RATHER A COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET. ALL FUTURE REPORTS WILL BE SUBMITTED BY WILLIAM COOK EUROPE, AS THEY ARE THE MANUFACTURER FOR THE COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET. NO ADDITIONAL REPORTS WILL BE SUBMITTED BY COOK INC. FOR THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    AS REPORTED, DURING AN UNKNOWN NUMBER OF PROCEDURES, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET WAS UNABLE TO RETRIEVE A COOK CELECT PLATINUM VENA CAVA FILTER SET. NON-STANDARD TECHNIQUES AND ADDITIONAL DEVICES HAVE BEEN REQUIRED TO COMPLETE THE RETRIEVALS. PER THE INITIAL REPORTER, NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION/CLARIFICATION WAS RECEIVED. THE COMPLAINT DEVICE WAS NOT A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, AS ORIGINALLY REPORTED, BUT RATHER A COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET (WILLIAM COOK EUROPE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779241 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown