BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE

    MDR report key: 20291130 · Received September 24, 2024

    Report

    Report Number
    9616099-2024-00315
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 4, 2024
    Report Date
    November 13, 2024
    Manufacturer
    CORDIS US CORP
    Product Code
    DTK
    UDI-DI
    10705032073592
    PMA / PMN Number
    K034050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, A PATIENT UNDERWENT PLACEMENT OF A 55 CM OPTEASE INFERIOR VENA CAVA (IVC) FILTER. RESISTANCE WAS FELT WHEN THE IVC FILTER WAS RELEASED, AND IT DID NOT RELEASE SUCCESSFULLY. THE FILTER WAS RELEASED BUT DID NOT RELEASE SUCCESSFULLY, MEANING IT WAS UNABLE TO EXPAND. THE FILTER WAS CORRECTLY RELEASED INTO THE IVC AND THEN WITHDRAWN, BUT IT WAS UNABLE TO BE RELEASED (EXPANDED). THERE WAS A LOT OF RESISTANCE IN DELIVERING THE FILTER THROUGH THE CSI, AND DIFFICULTY IN PULLING THE CSI BACK OVER THE OBTURATOR, LEADING TO THE USE OF ANOTHER OPTEASE FILTER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE INDICATION FOR FILTER INSERTION WAS DEEP VEIN THROMBOSIS (DVT). THE SIZE AND SHAPE OF THE VENA CAVA WERE NORMAL, AND ITS SIZE WAS MEASURED. THE VESSEL CHARACTERISTICS INCLUDED MODERATE CALCIFICATION AND THE PRESENCE OF ACUTE BENDS OR TORTUOSITY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND PREPPED ACCORDINGLY. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE SHEATH USED DURING DELIVERY OF THE FILTER WAS THE ONE INCLUDED IN THE FILTER PACKAGE. THE FILTER WAS NEVER IN AN ACUTE OR SHARP BEND IN THE DELIVERY TUBE WHILE IT WAS OUT OF THE STORAGE TUBE, AND THE DELIVERY SHEATH WAS NOT KINKED AT ANY TIME DURING DELIVERY. RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO DELIVER THE FILTER THROUGH THE SHEATH, AND THE DIAMETER OF THE IVC WAS MEASURED PRIOR TO DEPLOYMENT. THE OPERATOR IS TRAINED ON THE DEVICE. A NON-STERILE UNIT OF ¿OPTEASE VC FILTER OUS, 55CM FEMORAL ONLY¿ WAS RECEIVED INSIDE OF A CLEAR PLASTIC BAG. THE DEVICE WAS UNPACKED TO PROCEED WITH THE PRODUCT EVALUATION. THE PARTS INCLUDED ON THE SHIPMENT ARE THE OBTURATOR, THE BRITE TIP CATHETER SHEATH INTRODUCER (CSI), AND THE VESSEL DILATOR. THE VESSEL DILATOR WAS RETURNED INSERTED INTO THE BRITE TIP CSI. NEITHER THE FILTER NOR THE WINGED STORAGE TUBE WAS RETURNED FOR ANALYSIS. ALL COMPONENTS WERE THOROUGHLY INSPECTED OBSERVING NO DAMAGES OR ANOMALIES. NO OTHER OUTSTANDING DETAILS WERE OBSERVED. FUNCTIONAL ANALYSIS WAS PERFORMED. SINCE NEITHER THE FILTER NOR THE WINGED STORAGE TUBE WERE RETURNED FOR ANALYSIS, IT WAS NOT POSSIBLE TO DETERMINE IF ANY IMPEDED CONDITION ON THE FILTER CAN BE OBSERVED. THE VESSEL DILATOR AND THE BRITE TIP CSI WERE FLUSHED WITH WATER PRIOR TO THE EVALUATION. A SYRINGE WAS ATTACHED (FILLED WITH WATER) TO BOTH COMPONENTS TO BE FLUSHED AND THE WATER FLOWED THROUGH THE PARTS AND GOT OUT AT THE DISTAL TIP AS EXPECTED. NEITHER RESISTANCE TO THE WATER FLOW NOR LOOSE MATERIAL WAS OBSERVED DURING THE FLUSHING PROCEDURE. A LAB SAMPLE GUIDEWIRE WAS INSERTED COMPLETELY INTO THE VESSEL DILATOR BY THE DISTAL TIP AND THEN WAS WITHDRAWN COMPLETELY. NEITHER RESISTANCE NOR OBSTRUCTION WAS FELT DURING THE INSERTION/WITHDRAWN TEST. THE RETURNED VESSEL DILATOR WITH THE WIRE INSIDE AND THE OBTURATOR WERE INSERTED COMPLETELY INTO THE CANNULA OF THE RETURNED BRITE TIP CSI BY THE CAP. THEN BOTH DEVICES WERE WITHDRAWN COMPLETELY FROM THE BRITE TIP CSI. NEITHER RESISTANCE NOR OBSTRUCTION WAS FELT DURING THE INSERTION/WITHDRAWN TEST. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿FILTER~IMPEDED AND FILTER~INCOMPLETE EXPANSION¿ WAS NOT CONFIRMED. NEITHER THE FILTER NOR THE WINGED STORAGE TUBE WAS RETURNED FOR ANALYSIS. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿CATHETER SHEATH INTRODUCER (CSI)~ RESISTANCE/FRICTION- INNER LUMEN¿ WAS NOT CONFIRMED, NEITHER RESISTANCE/FRICTION NOR OBSTRUCTION WAS FELT DURING THE INSERTION/WITHDRAWN TEST. WITHOUT THE RETURN OF THE COMPLETE DEVICE, INCLUDING THE FILTER, AND WITHOUT IMAGES OF THE EVENT, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. PROCEDURAL FACTORS AND HANDLING PROCESS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿FILTER RELEASE (OR DEPLOYMENT) IS PERFORMED UNDER CONTINUOUS FLUOROSCOPY. PRIOR TO RELEASING THE OPTEASE® RETRIEVABLE FILTER FROM THE SHEATH INTRODUCER ENSURE THAT: A. THE INTENDED FILTER LOCATION IN THE INFERIOR VENA CAVA IS CORRECT. SHOULD THE FILTER LOCATION BE INCORRECT, REPOSITION THE SHEATH INTRODUCER; AND B. THE FILTER RETRIEVAL HOOK IS ORIENTATED TOWARDS THE CAUDAL END OF THE VENA CAVA. SHOULD THE FILTER ORIENTATION BE INCORRECT, REMOVE THE SHEATH INTRODUCER (WITH FILTER INSIDE) FROM THE PATIENT AND DISCARD THE SYSTEM. RECOMMENCE THE PROCEDURE USING A NEW STERILE SHEATH INTRODUCER AND STORAGE TUBE WITH FILTER.¿ THE PRODUCT EVALUATION DOES NOT SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, A PATIENT UNDERWENT PLACEMENT OF A 55 CM OPTEASE INFERIOR VENA CAVA (IVC) FILTER. RESISTANCE WAS FELT WHEN THE IVC FILTER WAS RELEASED, AND IT DID NOT RELEASE SUCCESSFULLY. THE FILTER WAS RELEASED BUT DID NOT RELEASE SUCCESSFULLY, MEANING IT WAS UNABLE TO EXPAND. THE FILTER WAS CORRECTLY RELEASED INTO THE IVC AND THEN WITHDRAWN, BUT IT WAS UNABLE TO BE RELEASED (EXPANDED). THERE WAS A LOT OF RESISTANCE IN DELIVERING THE FILTER THROUGH THE CSI, AND DIFFICULTY IN PULLING THE CSI BACK OVER THE OBTURATOR, LEADING TO THE USE OF ANOTHER OPTEASE FILTER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE INDICATION FOR FILTER INSERTION WAS DEEP VEIN THROMBOSIS (DVT). THE SIZE AND SHAPE OF THE VENA CAVA WERE NORMAL, AND ITS SIZE WAS MEASURED. THE VESSEL CHARACTERISTICS INCLUDED MODERATE CALCIFICATION AND THE PRESENCE OF ACUTE BENDS OR TORTUOSITY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND PREPPED ACCORDINGLY. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE SHEATH USED DURING DELIVERY OF THE FILTER WAS THE ONE INCLUDED IN THE FILTER PACKAGE. THE FILTER WAS NEVER IN AN ACUTE OR SHARP BEND IN THE DELIVERY TUBE WHILE IT WAS OUT OF THE STORAGE TUBE, AND THE DELIVERY SHEATH WAS NOT KINKED AT ANY TIME DURING DELIVERY. RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO DELIVER THE FILTER THROUGH THE SHEATH, AND THE DIAMETER OF THE IVC WAS MEASURED PRIOR TO DEPLOYMENT. THE OPERATOR IS TRAINED ON THE DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869461 OPTEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS US CORP 18275809 10705032073592

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female CORDIS SHEATH.ANOTHER FILTER.