InjuryGBS
UNKNOWN
Received Jun 29, 2023
Report 0002020735-2023-00002 · MDR key 17233575
Device
Generic name
Thoracic Catheter
Manufacturer
Axiom Medical IncProduct problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
Unknown
- Cardiac Tamponade
- Cardiac Tamponade
Narrative
Additional Manufacturer Narrative
NO INFORMATION PROVIDED ON PART NUMBER OR LOT. DEVICE ALLEGEDLY AN AXIOM THORACIC CATHETER, 32 FR.
Description of Event or Problem
IT WAS REPORTED TO BE A 32 FRENCH AXIOM THORACIC CATHETER, BUT NO DOCUMENTATION OR IMAGES OF THE CATHETER WERE PROVIDED. POST-SURGERY PATIENT REPORTED TO HAVE DEVELOPED TAMPONADE. SURGEON REMOVED CHEST TUBE AND FOUND IT FULL OF ONE CLOT.