PERICARDIOCENTESIS KIT.8.3F (2.77 MM).40 CM (15.7").PIGTAIL.
Received Mar 12, 2025 · Event occurred Feb 23, 2025
Report 1125782-2025-00002 · MDR key 21584749
Device
Generic name
Fluid Drainage Tray
Manufacturer
Merit Medical Systems Inc.Catalog number
PC801/A
Lot number
T2933767
Product problems
- Break
- Material Separation
- Break
- Material Separation
Patient
76 YR · Male
- Cardiac Arrest
- Cardiac Arrest
Narrative
Description of Event or Problem
MEDWATCH RECEIVED MW5167050 - THE ACCOUNT ALLEGES THAT IN THE CATH LAB WHILE PERFORMING A PERICARDIAL FLUID DRAINAGE PROCEDURE, THE PATIENT INITIALLY BECAME HEMODYNAMICALLY UNSTABLE AND A CODE BLUE WAS CALLED. THE CODE BLUE WAS TERMINATED PER THE FAMILIES REQUEST AND THE PATIENT EXPIRED. A GUIDEWIRE FROM PERICARDIOCENTESIS KIT WAS FOUND DAMAGED POST PROCEDURE.
Additional Manufacturer Narrative
THE SUSPECT MEDICAL DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.