MalfunctionOWQ

SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER

Received Dec 16, 2024 · Event occurred Dec 9, 2024

Report 20938010 · MDR key 20938010

Device

Generic name

Reprocessed Intravascular Ultrasound Catheter

Manufacturer

Sterilmed, Inc.

Model number

R10439011

Catalog number

R10439011

Lot number

2216058

Patient

74 YR · Male

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

Narrative

Description of Event or Problem

THE CONNECTOR FOR THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER WAS PARTIALLY SEPARATED FROM THE CATHETER LEAVING EXPOSED WIRES. CATHETER DID NOT ENTER THE BODY AND NO DAMAGE WAS DONE TO PATIENT OR OTHER EQUIPMENT. NO HARM TO PATIENT.