inforMED
InjuryGDY

Arterial Catheter Mini-Kit 20ga x 6"

Received Jul 29, 2026 · Event occurred May 1, 2026

Report 0001625425-2026-00998 · MDR key 50077223

Device

Generic name

Gauze/sponge, Internal, X-ray Detectable

Model number

498101

Lot number

11664984

Product problems

  • Leak/Splash

Patient

Not reported

  • Foreign Body In Patient

Narrative

Description of Event or Problem

Hours after the cardiac surgery, the left radial art line was noticed to be leaking. Upon inspection of the site at the bedside, it appeared as though the arterial line hub became separated from the catheter itself. As a result, almost the entirety of the 6" catheter was retained in the patient's left radial artery. On physical exam, a left radial pulse was present, and the hand appeared warm and well-perfused. Vascular surgery team was consulted. Bedside ultrasound was obtained which showed that the artery remained patent. The patient was taken to OR by hand surgery for removal of the foreign body.

Additional Manufacturer Narrative

It is unknown if the sample is available. As of the date of this report, the sample has not been returned. A follow-up report will be submitted upon investigation completion.