FLOWSTASIS DEVICE
Received Dec 30, 2025 · Event occurred Dec 21, 2025
Report MW5181422 · MDR key 23922188
Device
Generic name
Retention Device, Suture
Manufacturer
Inari Medical, Inc.Product problems
- Patient Device Interaction Problem
Patient
63 YR · Male
- Wound Dehiscence
- Hemorrhage/Blood Loss/Bleeding
- Wound Dehiscence
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
DECEDENT HAD THROMBECTOMY FOR OBSTRUCTIVE SADDLE PULMONARY THROMBOEMBOLUS ON (B)(6) 2025. HEMOSTASIS WAS OBTAINED AFTER THE PROCEDURE AND A PURSE[INVALID]STITCH WAS USED WITH THE FLOWSTASIS DEVICE. THERE WAS NO BLEEDING AT TIME OF DEVICE REMOVAL. SHORTLY THEREAFTER THE DECEDENT WAS FOUND ON THE FLOOR OF THE HOSPITAL ROOM IN A POOL OF BLOOD. THERE IS NO INDICATION OF AN ATTEMPT TO CALL FOR HELP, INDICATING POSSIBLE SUDDEN COLLAPSE. AUTOPSY SHOWED HEMORRHAGE FROM RIGHT FEMORAL VEIN ACCESS WITH DEHISCENCE OF TRACT EXTENDING FROM SKIN TO FEMORAL VEIN DEFECT. OTHER MEDICAL HISTORY INCLUDES HYPERTENSIVE AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE AND CURRENT HERPES ZOSTER.