BRYAN DUMON SILICONE STENT
Received Oct 28, 2019 · Event occurred Sep 5, 2019
Report 9244400 · MDR key 9244400
Device
Product problems
- Break
Patient
8760 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
SURGEON PLACED SILICONE STENT (12X30); AFTER MANIPULATION, THE STENT TORE. SURGEON HAD TO REMOVE STENT. WE ONLY HAD ONE OF THE IMPLANTS IN STOCK. SURGEON HAD TO REPLACE STENT WITH A DIFFERENT SIZE (NOT AS IDEAL AS INITIAL STENT BEING PLACED) (10X30). SURGEON BELIEVES THIS COMPROMISES PATIENT CARE, AS THE IDEAL STENT COULDN'T BE PLACED. PATIENT MAY NEED TO COME BACK TO RECEIVE PROPER SIZE IMPLANT. RIGID BRONCHOSCOPY WITH SILICONE STENT PLACEMENT. BRYAN DUMON SILICONE STENT 12X30(BD0398) LOT: 3831591 WAS IMPLANTED AND WHILE HE WAS REPOSITIONING IT (WITH A STENT GRASPER), THE STENT TORE. SO, HE HAD TO PLACE A 10X30(BD0374) LOT: 3831589 STENT BECAUSE WE DIDN'T HAVE ANOTHER 12X30 STENT AVAILABLE.