DENALI FEMORAL SYSTEM

Additional Manufacturer Narrative

H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE DENALI FILTER PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE DENALI FILTER PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. TWO PHOTOGRAPHS AND TWO VIDEOS WERE PROVIDED AND REVIEWED. PHOTO REVIEW SHOWED THE TUOHY-BORST ADAPTER AND STORAGE CHAMBER CONNECTED, WITH THE PUSHER ROD AND FILTER IN THE STORAGE TUBE VISIBLE. A SUBSEQUENT PHOTOGRAPH SHOWED THE HEALTHCARE PROFESSIONAL HOLDING THE PUSHER WIRE AND STORAGE TUBE. IN THAT PUSHER WIRE OBSERVED TO BE DETACHED. IN VIDEO REVIEW, THE PUSHER WIRE WAS DETACHED FROM THE PUSHER ROD WHILE THE HEALTHCARE PROFESSIONAL ATTEMPTED TO ADVANCE THE FILTER. A SECOND VIDEO FURTHER SHOWED TWO PUSHER RODS BEING HANDLED, INCLUDING ONE WITH THE DETACHED WIRE, DURING AN ATTEMPT TO ADVANCE THE FILTER. BASED ON THE PHOTOGRAPHIC AND VIDEO EVIDENCE PROVIDED, THE INVESTIGATION CONFIRMED THE REPORTED DETACHMENT AS THE PUSHER WIRE WAS OBSERVED DETACHED FROM THE PUSHER ROD. HOWEVER, THE INVESTIGATION REMAINS INCONCLUSIVE FOR THE REPORTED FAILURE TO ADVANCE ISSUE BECAUSE NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DETACHMENT AND FAILURE TO ADVANCE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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 BD.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN RIGHT FEMORAL VEIN USING A DENALI FILTER. DURING THE PROCEDURE, THE FILTER WAS JAMMED INSIDE THE STORAGE TUBE AND COULD NOT BE ADVANCED NORMALLY. AFTER RETRIEVING IT FROM THE BODY, IT WAS FOUND THAT THE METAL ROD AT THE TIP OF THE PUSHER HAD BEEN DISLODGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.