BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 17648849 · Received August 30, 2023

    Report

    Report Number
    3002808486-2023-00228
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    May 31, 2023
    Report Date
    August 30, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF#: (B)(4). G4) PMA/510(K): K211875. SUMMARY OF INVESTIGATIONAL FINDINGS: THE PHYSICIAN HAD SOME CHALLENGES WITH A FILTER DEPLOYMENT; THE FILTER DID NOT DEPLOY AS EXPECTED AND SUBSEQUENTLY THERE WAS AN ISSUE WITH THE SHEATH (GTRS). THE PATIENT OUTCOME IS UNKNOWN, DUE TO LIMITED INFORMATION PROVIDED. THE INVESTIGATION IS BASED ON THE LIMITED INFORMATION PROVIDED AND A DEVICE EVALUATION OF THE RETURNED FILTER AND A GTRS (B)(4) RETURNED WITH THE COMPLAINT DEVICE. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ALL DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE RELEASE AND NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATION. IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE OCCURRED BASED ON THE LIMITED INFORMATION MADE AVAILABLE TO US. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN HAD SOME CHALLENGES WITH A FILTER DEPLOYMENT. THE FILTER DID NOT DEPLOY AS EXPECTED AND SUBSEQUENTLY THERE WAS AN ISSUE WITH THE SHEATH. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302466 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4254559 10827002345055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening