MalfunctionFTJ
TRI-EX
Received Nov 16, 2015 · Event occurred Sep 5, 2015
Report 5224968 · MDR key 5224968
Device
Generic name
Single Use 3-lumen Balloon Catheter And Balloon
Manufacturer
Cook MedicalModel number
8.5MMCatalog number
G22530
Lot number
W3603285
Product problems
- Device Operates Differently Than Expected
Patient
78 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ACCORDING TO THE DEPARTMENT'S REPORT, "THE EXTRACTION BALLOON IS SUPPOSED TO BLOW UP A WHOLE 360 DEGREES. IT WOULD NOT BLOWN UP CORRECTLY." INSTEAD OF BLOWING UP LIKE A SPHERE, IT BLEW UP INTO A KIDNEY SHAPE. THERE WAS NO PATIENT IMPACT, NO COMPLICATIONS.