BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 4036825 · Received August 20, 2014

    Report

    Report Number
    1820334-2014-00401
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    July 10, 2013
    Report Date
    August 4, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH CATALOG NUMBER IS UNK, BUT COULD BE EITHER K072240 OR K043509. EVENT EVAL: STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    NO PRODUCT OR IMAGING WAS PROVIDED FOR EVALUATION HOWEVER, DURING INVESTIGATION, A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC), SPECIFICATIONS, TRENDS WAS CONDUCTED. NO LOT NUMBER WAS PROVIDED NOR INFORMATION REGARDING IMPLANT DATE HOWEVER, IT IS KNOWN THAT FRACTURE IS SECONDARY TO PERFORATION OF IVC FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK SEVERAL CASE REPORTS IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. CHANGES TO THE FILTER CONFIGURATION AND TO THE FILTER PLACEMENT, IS KNOWN TO CAUSE STRESS AND POSSIBLY FRACTURE TO THE FILTER WIRES DUE TO E.G RESPIRATORY MOVEMENTS. ALSO SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD ALSO CONTRIBUTE TO CHANGE IN FILTER CONFIGURATION. FRACTURE OF THE WIRE IS AN UNCOMMON, BUT KNOWN RISK IN RELATION TO FILTER IMPLANT. A REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE: IN POTENTIAL ADVERSE EVENTS ARE MENTIONED: DAMAGE TO THE VENA CAVA, PULMONARY EMBOLISM, FILTER EMBOLIZATION, VENA CAVA PERFORATION, VENA CAVA OCCLUSION OR THROMBOSIS, HEMORRHAGE, HEMATOMA AT VASCULAR ACCESS SITE, INFECTION AT VASCULAR ACCESS SITE, DEATH. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION RESULTS, WE ARE UNABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE FOR THE DIFFICULTY EXPERIENCED. WE WILL CONTINUE TO MONITOR THIS DEVICE. PER QUALITY ENGINEERING RISK ASSESSMENT (QERA), NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A PT UNDERWENT A GUNTHER TULIP FILTER RETRIEVAL ON (B)(6) 2013 AT HOSPITAL 2. THE PHYSICIAN INDICATED THAT THE FILTER HAD FRACTURED AND THAT THE RETRIEVAL WAS UNSUCCESSFUL AT HOSPITAL 1 BECAUSE THE HOOK OR LEGS WERE EMBEDDED. HOWEVER, THE FILTER WAS SUCCESSFULLY REMOVED AT HOSPITAL 2. AT THIS TIME, NO ADD'L INFO HAS BEEN PROVIDED, BUT THE COOK REP IS ATTEMPTING TO GATHER ADD'L INFO.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502207 UNK DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other