BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI JUGULAR SYSTEM

    MDR report key: 6118634 · Received November 21, 2016

    Report

    Report Number
    2020394-2016-01093
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 25, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040795
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. VISUAL INSPECTION: ALL 6 ARMS AND 6 LEGS WERE PRESENT AND INTACT. NO LIMBS WERE CROSSED. NO ANOMALIES TO THE FILTER WERE NOTED. DIMENSIONAL EVALUATION: ALL DIMENSIONAL MEASUREMENTS MET THE REQUIRED SPECIFICATIONS. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED FOR REVIEW. CONCLUSION: THE DEVICE WAS RETURNED. NO CROSSED OR BENT LIMBS WERE IDENTIFIED ON THE PHYSICAL SAMPLE. BASED ON THE DIMENSIONAL EVALUATION THE INVESTIGATION WAS INCONCLUSIVE FOR FAILURE TO EXPAND. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT WAS UNKNOWN AS IMAGES WERE NOT PROVIDED. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: - DELIVERY OF THE DENALI FILTER THROUGH THE INTRODUCER SHEATH IS ADVANCE ONLY. RETRACTION AND TWISTING OF THE PUSHER DURING DELIVERY COULD RESULT IN DISLODGEMENT OF THE FILTER, CROSSING OF FILTER LEGS OR ARMS, AND COULD PREVENT THE FILTER FROM FURTHER ADVANCEMENT WITHIN THE INTRODUCER SHEATH. PRECAUTIONS: - CARE SHOULD BE TAKEN TO ENSURE THE CONNECTION BETWEEN THE INTRODUCER SHEATH HUB AND THE FILTER STORAGE TUBE IS TIGHT; HOWEVER, THE USE OF EXCESSIVE FORCE WHICH CAN CAUSE SLIPPAGE OF THE THREADS AND/OR BREAKAGE OF THE HUB SHOULD BE AVOIDED. - DO NOT DELIVER THE FILTER BY PUSHING IT BEYOND THE END OF THE INTRODUCER SHEATH. TO ACHIEVE PROPER PLACEMENT, UNSHEATH THE STATIONARY FILTER BY WITHDRAWING THE INTRODUCER SHEATH. DO NOT TWIST THE PUSHER AT ANYTIME DURING THIS PROCEDURE. POTENTIAL COMPLICATIONS: - FAILURE OF FILTER EXPANSION/INCOMPLETE EXPANSION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS OR NO IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, THE FILTER LEGS ALLEGEDLY CROSSED AND WOULD NOT OPEN. IT WAS FURTHER REPORTED THAT THE FILTER WAS CAPTURED AND RETRIEVED AND ANOTHER VENA CAVA FILTER WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, THE FILTER LEGS ALLEGEDLY CROSSED AND WOULD NOT OPEN. IT WAS FURTHER REPORTED THAT THE FILTER WAS CAPTURED AND RETRIEVED AND ANOTHER VENA CAVA FILTER WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767203 DENALI JUGULAR SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFAQ1137 00801741040795

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR