SURFACER® INSIDE-OUT®
Received Nov 25, 2025 · Event occurred Sep 1, 2025
Report 1721504-2025-00624 · MDR key 23645279
Device
Generic name
Reverse Central Venous Recanalization System
Manufacturer
Merit Medical Systems Inc.Catalog number
600200/C
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Cardiac Arrest
- Cardiac Arrest
Narrative
Description of Event or Problem
IN A LITERATURE ARTICLE (PUPPALA ET AL., 2025), CUSTOMER REPORTS " AN ADVERSE EVENT ASSOCIATED WITH THE SURFACER SYSTEM WAS IDENTIFIED IN A 2025 U.S. CASE REPORT. A PATIENT SUFFERED A CARDIAC ARREST DURING OR FOLLOWING SURFACER PROCEDURE. DETAILS OF RESUSCITATION AND PATIENT OUTCOME WERE NOT SPECIFIED IN THE ABSTRACT BUT WERE TEMPORALLY LINKED TO THE DEVICE USE."
Additional Manufacturer Narrative
THE SUSPECT MEDICAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO LOT NUMBER WAS PROVIDED; THUS, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AND A SEARCH OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED.