EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
Received Jul 21, 2026
Report 2015691-2026-17009 · MDR key 25893305
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Swelling/ Edema
Narrative
Description of Event or Problem
AS REPORTED, AFTER CARDIAC SURGERY AND ADMISSION TO THE ICU, SUBCUTANEOUS SWELLING WAS OBSERVED AROUND THE INTERNAL JUGULAR VEIN/INSERTION SITE WITH THIS OXIMETRY CATHETER. NO SKIN DISCOLORATION WAS NOTED ON THE INSERTION SITE. THE CATHETER WAS REMOVED FROM THE PATIENT THE FOLLOWING DAY. NO ADDITIONAL TREATMENT WAS REQUIRED DUE TO THIS EVENT. THE PATIENT CONDITION IS RECOVERED WITHOUT ANY ISSUES. IT IS UNCLEAR WHETHER THE SWELLING WAS NOTED ON THE SAME DAY OF CATHETER INSERTION DATE. THE CUSTOMER REQUESTED TO CONFIRM WHETHER THIS EVENT OCCURRED DUE TO DEVICE MALFUNCTION OR PROCEDURE. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL PRODUCT CODES INCLUDE; DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION. DXG: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.