BASIC COMPAK INFLATION DEVICE
Received Apr 23, 2025 · Event occurred Apr 9, 2025
Report 3011642792-2025-00049 · MDR key 21891999
Device
Generic name
Inflation Device
Manufacturer
Merit Medical Systems MexicoCatalog number
IN4130/CNK
Lot number
I3001130
Product problems
- Failure to Deflate
- Failure to Deflate
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND TWO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE IDENTIFIED.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PROCEDURE, THE INFLATION DEVICE WAS UNABLE TO DEFLATE THE BALLOON. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.