BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5938417 · Received September 9, 2016

    Report

    Report Number
    3002808486-2016-01036
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Report Date
    August 17, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG #: UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT # IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K07334 OR K090140. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4) . CATALOG#: UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER, EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. PMA 510(K): SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K07334 OR K090140. MFG DATE: UNKNOWN AS LOT# IS UNKNOWN. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE IMAGING CONFIRMED THE REPORTED FRACTURE. ONE FILTER LEG IS FRACTURED. THE OTHER 3 PRIMARY FILTER LEGS APPEAR ATTACHED. THE IMAGE QUALITY IS TOO POOR TO DETERMINE IF THE SECONDARY LEGS ARE STILL PRESENT. HOWEVER, WITHOUT CROSS-SECTIONAL IMAGING, THE EXACT LOCATION OF THE FRACTURED PRIMARY FILTER LEG IS INDETERMINATE. IN THIS CASE PATIENT WAS SYMPTOMATIC REPORTED AS CHEST PAIN. THE COMPLAINT REPORT STATES THE FILTER WAS PLACED ON (B)(6) 2010, BUT THE TIME OF PRIMARY FILTER LEG FRACTURE AND MIGRATION IS UNDETERMINATE. FILTER FRACTURE IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. FRACTURE OF A FILTER LEG CAN BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL STRESSED POSITION. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO THE INITIAL REPORTER: AS REPORTED TO CUSTOMER RELATIONS: "ONE OF OUR NEW (B)(6) PHYSICIANS DID A CONSULT THE OTHER DAY WITH A PATIENT WHO HAS A CELECT IVC FILTER. IT APPEARS THAT ONE OF THE STRUTS HAS BROKEN OFF AND MIGRATED." PATIENT OUTCOME: INFORMATION HAS BEEN REQUESTED, BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO THE INITIAL REPORTER: AS REPORTED TO CUSTOMER RELATIONS: "ONE OF OUR NEW IR PHYSICIANS DID A CONSULT THE OTHER DAY WITH A PATIENT WHO HAS A CELECT IVC FILTER. IT APPEARS THAT ONE OF THE STRUTS HAS BROKEN OFF AND MIGRATED." PATIENT OUTCOME: INFORMATION HAS BEEN REQUESTED, BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590191 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1