MERIT'S PERICARDIOCENTESIS PROCEDURE KITS
Received Mar 21, 2006 · Event occurred Mar 2, 2006
Report 1628221-2006-00005 · MDR key 691280
Device
Generic name
Pericardiocentesis Kit
Manufacturer
Merit Medical Systems, Inc.Model number
NACatalog number
PC200/A
Lot number
F415628
Product problems
- Difficult to Remove
Patient
*
- Surgical procedure
- Drainage
Narrative
Description of Event or Problem
THE PT WAS HAVING A PERICARDIOCENTESIS PROCEDURE TO DRAIN PERICARDIAL FLUID, A MERIT 6F STRAIGHT PERICARDIOCENTESIS CATHETER, WAS SUCCESSFULLY PLACED BY THE PHYSICIAN. THE PERICARDIAL SAC WAS DRAINED BY APPLYING SUCTION TO THE CATHETER USING A SYRINGE ATTACHED TO THE CATHETER HUB AND ASPIRATING. UPON COMPLETION OF DRAINGAGE, THE PHYSICIAN TRIED TO REMOVE THE CATHETER. THE RECEIVED COMPLAINT REPORT INDICATES THAT A VACUUM HAD HEEN CREATED BETWEEN THE CATHETER TIP AND THE PERICARDIAL WALL, MAKING REMOVAL DIFFICULT. TO THE BEST OF MERIT'S KNOWLEDGE THE PT IS DOING FINE. THERE WAS NO REPORTED HARM OR INJURY.