BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 1862376 · Received October 8, 2010

    Report

    Report Number
    9610978-2010-00190
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE ADVANCING THE FILTER THROUGH THE DELIVERY SHEATH, THE FILTER "STOPPED ADVANCING." THE USER PUSHED HARDER WITHOUT SUCCESS AND THE FILTER AND SHEATH WERE REMOVED TOGETHER FROM THE PATIENT. IT WAS NOTED THAT THE SHEATH WAS SPLIT AND THE FILTER WAS CAUGHT ON THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE UNIT OPTEASE 55 CM "OPTEASE VENA CAVA FILTER (B)(4)" WAS RECEIVED COILED INSIDE A PLASTIC BAG. DRY BLOOD RESIDUES WERE NOTED IN UNIT. THE STENT WAS ADVANCED INSIDE THE CATHETER SHEATH INTRODUCER (CSI). KINKS WERE NOTED AT 41 AND 45 CM FROM OBTURATOR DISTAL END. THE STENT WAS ADVANCED INSIDE THE CSI AT 37 CM APPROXIMATELY FROM SUTURE COLLAR. THE CSI WAS SPLIT/FRAYED AT 36 CM APPROXIMATELY FROM SUTURE COLLAR. CSI KINKS WERE NOTED AT 36, 37 AND 42 CM FROM SUTURE COLLAR. THE CSI, STORAGE TUBE, STENT AND OBTURATOR WERE RETURNED, AND THE UNIT WAS FLUSHED, AN ATTEMPT TO MOVE THE STENT INTO NON KINKED AREAS WAS MADE, THE STENT NAVIGATES WITHIN THE NON KINKED AREAS OF THE CSI SUCCESSFULLY, AND NO RESISTANCE OR FRICTION WAS FELT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED CUSTOMER COMPLAINT WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. ACCORDING TO THE VISUAL ANALYSIS PERFORMED, IT SEEMS THAT OBSERVED CSI KINKS COULD BE POSSIBLE CONTRIBUTORS TO THE REPORTED FAILURE, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. IT IS LIKELY THAT ONE OR MORE OF THE FILTER BARBS ENGAGED WITH THE SHEATH PREVENTING FURTHER ADVANCEMENT OF THE FILTER. WHEN THE PHYSICIAN USED ADDITIONAL FORCE (PER THE IFU; IF RESISTANCE IS MET DURING ANY STAGE OF THE PROCEDURE, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE BEFORE PROCEEDING. IT IS THE RESPONSIBILITY OF THE PHYSICIAN TO USE HIS/HER JUDGMENT, BASED ON PATIENT SAFETY AND CLINICAL EXPERIENCE, REGARDING THE ACCEPTABILITY LEVEL OF ANY RESISTANCE AND/OR WHETHER TO CONTINUE OR ABORT THE RETRIEVAL ATTEMPT. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE SYSTEM AS A UNIT.) THIS LIKELY CAUSED ONE OR MORE OF THE BARBS TO PENETRATE THE CATHETER WALL. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY VESSEL CHARACTERISTICS AND THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15116901 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS OR EXCURSIONS WERE ISSUED FOR THIS LOT 15116901. (B)(4) NON COATED SUBASSEMBLY LOTS 15113190 AND 15113860 WERE REVIEWED AND NO UNITS WERE REJECTED DURING THE ASSEMBLY OF THESE LOTS. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THESE LOTS. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. CANNULA ASSY (B)(4). SUBASSEMBLY LOTS 15101910 AND 15100370 WERE REVIEWED AND NO UNITS WERE REJECTED DURING THE ASSEMBLY OF THESE LOTS. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THESE LOTS. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. CSI SUBASSEMBLY WAS REVIEWED. IT WAS OBSERVED DURING REVIEW THAT NO NON-CONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. MANUFACTURING RECORDS FOR LOT 15116901 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO NITINOL DEVICES & COMPONENTS (NDC), (B)(4) AND FILTER LOT NUMBERS 512956,513269 AND 512954; AND THE RESULTS INDICATE THAT THE FILTER SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING INSERTION OF A FILTER IN THE (IVC) INFERIOR VENA CAVA WITH A FEMORAL APPROACH, THE OPTEASE FILTER STOPPED ADVANCING. EVEN IT WAS PUSHED HARDER WITH AN OBTURATOR, IT DID NOT ADVANCE. THE OPTEASE FILTER WAS REMOVED TOGETHER WITH THE SHEATH (ACCESSORY FOR THE COMPLAINT PRODUCT) FROM THE PATIENT'S BODY. IT WAS FOUND THAT THE SHEATH WAS SPLIT AND THE FILTER WAS CAUGHT ON THE SHEATH. OTHER NEW PRODUCT (DETAILS UNKNOWN) WAS USED WITH JUGULAR APPROACH AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THE COMPLAINT PRODUCT WILL BE RETURNED TO YOUR SIDE FOR ANALYSIS. THE VESSEL WAS NOT CALCIFIED AND THE VESSEL TORTUOSITY, AND THE RATE OF STENOSIS WERE UNKNOWN. DURING INSERTION OF THE FILTER, CONSTANT FLUOROSCOPY WAS PERFORMED, AND THE SHEATH WAS NOT KINK OR BEND. THE INDICATION FOR FILTER INSERTION WAS DVT. THROMBUS WAS NOT PRESENT AT DELIVERY SITE. PRE/POST IMAGING WAS COMPLETED. THE OBTURATOR REMAINED FIXED WHILE THE DEPLOYMENT SHEATH WAS PULLED BACK OVER THE OBTURATOR, AND IT WAS VERIFIED UNDER FLUOROSCOPY THAT THE FILTER WAS NOT IN A SIDE VESSEL. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. 15116901

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH