Intra-Aortic Balloon Catheter Kit
Received Jul 31, 2026 · Event occurred May 21, 2026
Report MW6000153 · MDR key 50098065
Device
Generic name
System, Balloon, Intra-aortic And Control
Model number
IAB-05850-LWS-SCLot number
18F25M0083
Product problems
- Fluid/Blood Leak
- Difficult to Remove
- Material Rupture
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
- Cardiogenic Shock
Narrative
Description of Event or Problem
This patient came through the ER with an acute MI and was taken to the cath lab emergently. The team had to place an intra-aortic balloon pump since the patient was in cardiogenic shock. After placing the IABP inside the aorta, the physician started noticing blood coming out of the helium inflation port. This was an indication that the balloon has ruptured and that if connected to the helium inflation port, it would lead to helium inflation into the central aortic circulation that could be life threatening due to air embolism. The case was immediately stopped, and physician attempted to retract the IABP back out of the groin, but it would not come out due to the ruptured balloon.Physician had to call vascular surgery emergently to move the patient to the Operating Room, open the patient's groin under general anesthesia to remove the ruptured IABP and place a new one in the hybrid operating room.