BASIXCOMPAK¿
Received Aug 27, 2025 · Event occurred Aug 8, 2025
Report 1721504-2025-00307 · MDR key 22909986
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Merit Medical SystemsCatalog number
IN4430/K
Lot number
I3074770
Product problems
- Mechanical Problem
- Device Dislodged or Dislocated
- Unintended Movement
- Mechanical Problem
- Device Dislodged or Dislocated
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT UPON INSERTING A STENT, THE RING ON THE INFLATOR BODY BECAME UNSCREWED, CAUSING A DELAY IN THE DEFLATION OF THE STENT BALLOON. AFTER TIGHTENING THE RING, THE BALLOON DEFLATED SUCCESSFULLY. URGENT REPLACEMENT OF THE INFLATOR TO CONTINUE THE PROCEDURE.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT WERE IDENTIFIED.