InjuryNLG
PENTARAY D
Received Aug 28, 2025 · Event occurred Aug 8, 2025
Report MW5175361 · MDR key 22915942
Device
Generic name
Catheter, Intracardiac Mapping, High-density, Reprocessed
Model number
D128211Product problems
- Application Program Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPROCESSED PENTARAY PLACED IN PATIENT'S BODY. MAPPING SYSTEM WITH SENSOR ERROR AND UNABLE TO DETECT CATHETER. TRIED REPLACING THE CABLE AND CATHETER STILL WITH SENSOR ERROR. REPLACED CATHETER WITH NEW CATHETER AND ABLE TO DETECT THIS CATHETER WITH SYSTEM. MANUFACTURER NAME, JOHNSON AND JOHNSON.