MalfunctionOWQ

CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR

Received Nov 20, 2024 · Event occurred Oct 16, 2024

Report 20733675 · MDR key 20733675

Device

Generic name

Reprocessed Intravascular Ultrasound Catheter

Manufacturer

Sterilmed, Inc.

Model number

ACU10135936

Catalog number

ACU10135936

Lot number

2211031

Patient

67 YR · Male

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

Narrative

Description of Event or Problem

REPROCESSED CATHETER INSERTED INTO BODY, POOR IMAGE QUALITY; CATHETER REMOVED FROM BODY. DIFFERENT NEW CATHETER OPENED, PROBLEM SOLVED. NO HARM TO PATIENT.