MalfunctionNLH
NA
Received Sep 16, 2022 · Event occurred Aug 19, 2022
Report 15437457 · MDR key 15437457
Device
Generic name
Catheter, Recording, Electrode, Reprocessed
Manufacturer
Sterilmed, Inc.Model number
DAI401450Catalog number
DAI401450
Lot number
2175167
Product problems
- Break
Patient
27375 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MID 70¿S FEMALE WITH HISTORY OF ATRIAL FIBRILLATION. IN EP LAB FOR PROCEDURE: ELECTROPHYSIOLOGY STUDY, RF ABLATION POSTERIOR WALL, AF DRIVER. WHEN THE REPROCESSED JOSEPHSON EP CATHETER WAS REMOVED FROM THE BOX, THE END WAS BROKEN OFF. NOT USED ON THE PATIENT. MANUFACTURER RESPONSE FOR EP CATHETER, JOSEPHSON (PER SITE REPORTER). WILL OBTAIN.