inforMED
MalfunctionOGE

PERIFIX

Received Oct 21, 2024 · Event occurred Oct 3, 2024

Report MW5161280 · MDR key 20506167

Device

Generic name

Epidural Anesthesia Kit

Model number

332097

Lot number

0061944517

Patient

76 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING THE PLACEMENT OF THE EPIDURAL CATHETER RESISTANCE WAS MET, AND THE CATHETER COULD NOT BE THREADED ANY FURTHER. A DECISION WAS MADE TO REMOVE THE CATHETER HOWEVER IT FELT STUCK. THE WHOLE EPIDURAL NEEDLE WAS REMOVED BUT THERE WAS RESISTANCE TO REMOVING THE REST OF THE CATHETER. THE TIP OF THE CATHETER COULD NOT BE VISUALIZED INDICATING THERE WAS HIGH PROBABILITY OF A RETAINED EPIDURAL CATHETER IN THE LUMBAR AREA. AN MRI CONFIRMED CATHETER WAS RETAINED IN THE EPIDURAL SPACE. AN INSPECTION OF THE CATHETER SHOWED IT WAS SHREDDED.