BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 4036822 · Received August 20, 2014

    Report

    Report Number
    1820334-2014-00400
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    March 20, 2013
    Report Date
    August 4, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K072240
    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

    CATALOG # IS UNKNOWN BUT THE 510(K) # COULD BE EITHER K072240 OR K043509. INVESTIGATION EVALUATION IS BASED SOLELY ON EVENT DESCRIPTION, SINCE NO DEVICE OR IMAGING WAS PROVIDED FOR EXAMINATION. DURING INVESTIGATIONS, A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC), SPECIFICATIONS, AND TRENDS WAS CONDUCTED. PER THE EVENT DESCRIPTION. A PATIENT UNDERWENT GUNTHER TULIP FILTER RETRIEVAL ON (B)(6) 2013 AT HOSPITAL 2 ((B)(6)). THE PHYSICIAN INDICATED THAT THE FILTER HAD FRACTURED AND THAT THE RETRIEVAL FAILED AT HOSPITAL 1 DUE TO HOOK OR LEGS EMBEDDED AND AN EXTRAVASCULAR PIECE IN THE VERTEBRAL BODY, BUT WAS SUCCESSFULLY REMOVED AT HOSPITAL 2. IT IS UNKNOWN WHEN THE FILTER WAS IMPLANTED AND IF PATIENT UNDERWENT ANY SURGERY DURING FILTER IMPLANT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. IT IS COOKS' EXPERIENCE 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 (IFU). 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 ABOVE, THE EXACT ROOT CAUSE FOR THE REPORTED DIFFICULTY CAN NOT BE DETERMINED WITH CERTAINTY. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR THIS DEVICE. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A PT UNDERWENT GUNTHER TULIP FILTER RETRIEVAL ON (B)(6) 2013 AT HOSPITAL 2. THE PHYSICIAN INDICATED THAT THE FILTER HAD FRACTURED AND THAT THE RETRIEVAL FAILED AT HOSPITAL 1 DUE TO HOOK OR LEGS EMBEDDED AND AN EXTRAVASCULAR PIECE IN THE VERTEBRAL BODY, BUT WAS SUCCESSFULLY REMOVED AT HOSPITAL 2. THE COOK REP IS ATTEMPTING TO GATHER ADD'L INFO.

    Description of Event or Problem · 1

    NO INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502206 UNK DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other