BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 9165238 · Received October 8, 2019

    Report

    Report Number
    3002808486-2019-01667
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    September 19, 2019
    Report Date
    July 27, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). H11) CORRECTED DATA COMPARED WITH MEDWATCH REPORT (B)(4). B4) (B)(6)2019 D1) CELECT IVF FILTER D3) COOK MEDICAL LLC BLOOMINGTON, IN UNITED STATES 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. - ATTACHMENT: [MEDWATCH VOLUNTARY REPORT.PDF]

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: NO IMAGING WAS AVAILABLE AND NO PRODUCT WAS RETURNED. BASED ON THE VERY LIMITED INFORMATION PROVIDED IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER TO FRACTURE WITH ONE LEG ¿IN PULMONARY ARTERY, ALSO DEEPLY PENETRATED WITH DUODENAL INTERACTION¿ APPROX. TEN YEARS AFTER FILTER PLACEMENT.¿ IT IS NOTED THAT THE FILTER AND THE FRACTURED LEG WERE REMOVED IN THE SAME PROCEDURE. FILTER FRACTURE HAS BEEN REPORTED AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. FRACTURE OF A FILTER LEG MAY BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL, STRESSED POSITION, SUCH AS A FILTER LEG PENETRATING/PERFORATING THE IVC; OR A FILTER LEG BEING CAUGHT IN A SIDE BRANCH (E.G., A RENAL VEIN). OTHER POTENTIAL CAUSES OF FILTER FRACTURE MAY INCLUDE EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). RETRIEVAL OF A FRACTURED FILTER OR FILTER FRAGMENTS (INCLUDING EMBOLIZED FRAGMENTS) USING ENDOVASCULAR TECHNIQUES HAS BEEN REPORTED. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER FRACTURE, FILTER OR FILTER FRAGMENT EMBOLIZATION, TRAUMA TO ADJACENT STRUCTURES. 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, BUT THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. 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.

    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

    (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER. APPROPRIATE TERM/CODE NOT AVAILABLE FOR PERFORATION. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CELECT FILTER PLACED IN 2009 (ESTIMATED BY PATIENT) FOUND TO HAVE FRACTURED WITH ONE ARM IN RIGHT PULMONARY ARTERY, ALSO DEEPLY PENETRATED WITH DUODENAL INTERACTION INITIALLY THOUGHT TO BE DUODENAL MASS ENDOSCOPY, SPINAL INTERACTION AND PSOAS INTERACTION. REMOVAL WITH FORCEPS AND REMOVED FRAGMENT FROM LUNG IN SAME PROCEDURE. THE FILTER IS OUT AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962698 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R