BASIXCOMPAK¿
Received Jul 7, 2026 · Event occurred May 22, 2026
Report 3011642792-2026-00119 · MDR key 25736240
Device
Generic name
Catheter-balloon Inflator, Single-use
Manufacturer
Merit Medical Systems, Inc.Catalog number
IN4130/CNK
Lot number
I3146015
Product problems
- Inflation Problem
- Detachment of Device or Device Component
- Separation Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE DEVICE FAILED TO INFLATE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. PER PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CUSTOMER, THE FAILURE WAS OBSERVED. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.