MERIT S-MAK¿
Received Jun 25, 2026 · Event occurred May 25, 2026
Report 3011642792-2026-00101 · MDR key 25619296
Device
Generic name
Dilator, Vessel, For Percutaneous Catheterization
Manufacturer
Merit Medical Systems, Inc.Catalog number
S-MAK401N/C
Lot number
I3160925
Product problems
- Fracture
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
CUSTOMER REPORTED A CENTRAL VENOUS CATHETER (CVC) WAS INSERTED INTO THE VEIN OVER A WIRE. WHEN REMOVING THE WIRE FROM THE CATHETER, THE WIRE STARTED TO STRETCH AND SUDDENLY BROKE. THE CVC HAD TO BE REMOVED FROM THE PATIENT AND AFTERWARDS IT WAS NOTICED THAT A THIN METAL WIRE FROM THE WIRE WAS STILL PROTRUDING THROUGH THE SKIN ON THE PATIENT'S NECK. THIS WAS REMOVED AND A FLUOROSCOPY WAS USED TO CHECK THAT NO FOREIGN MATERIAL WAS LEFT IN THE PATIENT.