G30-01 VIS-RX MICRO-IMAGING CATHETER
Received May 26, 2026 · Event occurred May 7, 2024
Report 3011578544-2026-00021 · MDR key 25282144
Device
Generic name
Catheter, Intravascular, Diagnostic
Manufacturer
Gentuity, LlcModel number
G30-01Catalog number
G30-01
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
I RECEIVED A PHONE CALL LAST NIGHT FROM LEAD TECH AT TGH. THE CATHETER WAS STUCK IN THE PIM. I INSTRUCTED HIM TO POWER DOWN THE SYSTEM AND REMOVE CATHETER ONCE SYSTEM WAS OFF. I WATCHED VIA FACETIME AND INSTRUCTED THEM ON HOW TO REMOVE CATHETER.
Additional Manufacturer Narrative
THE SITE REPORTED THE CATHETER WAS STUCK IN THE PIM. THE USER POWERED DOWN THE SYSTEM AND REMOVED THE CATHETER WITH GUIDANCE. LOGS INDICATED SYMPTOMS CONSISTENT WITH A FAILED CATHETER, LIKELY DUE TO BUCKLING, CAUSING THE PIM JAWS NOT TO REMAIN FULLY FORWARD AND MAKING CATHETER EXTRACTION DIFFICULT. THE COMPLAINT IS CONFIRMED.