MalfunctionPFJ
CVX-RIPE
Received Apr 20, 2026 · Event occurred Mar 21, 2026
Report 24924662 · MDR key 24924662
Device
Generic name
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Manufacturer
Utah Medical Products, Inc.Model number
CVX-100Catalog number
CVX-100
Lot number
1251593
Patient
22 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
UTAH CATHETER BROKE INSIDE OF PATIENT. THE TOP BALLOON BECAME DISLODGED INSIDE THE PATIENT STILL BLOWN UP AND INTACT. THE BOTTOM BALLOON STILL ATTACHED TO THE CATHETER AND REMOVED FROM PATIENT WHILE THE TOP BALLOON WAS INTACT STILL INSIDE PATIENT, HAD TO BE MANUALLY REMOVED BY PROVIDER.