MalfunctionOWQ

ACUNAV DIAGNOSTIC ULTRASOUND

Received Oct 8, 2024 · Event occurred Sep 4, 2024

Report 20396977 · MDR key 20396977

Device

Generic name

Reprocessed Intravascular Ultrasound Catheter

Manufacturer

Sterilmed, Inc.

Model number

ACU10135936

Catalog number

ACU10135936

Lot number

2207892

Patient

85 YR · Female

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

Narrative

Description of Event or Problem

REPROCESSED ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER PLACED IN GROIN ACCESS SITE, STEERING MECHANISM OF CATHETER WOULD NOT TURN, SO ICE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER.