Model Number 3822 |
Device Problems
Fracture (1260); Material Rupture (1546)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/13/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that the balloon fractured.A 10/2.75 flextome was selected for use.During introduction inside the patient, it was noted that the balloon fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
|
|
Manufacturer Narrative
|
F10.Corrected device codes fracture 1260 to material rupture 1546.
|
|
Event Description
|
It was reported that the balloon fractured.A 10/2.75 flextome was selected for use.During introduction inside the patient, it was noted that the balloon fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.It was further reported that the target lesion was in the left anterior descending artery.The balloon burst upon first inflation and was not fractured.The device was then completely removed within the catheter without any intervention.
|
|
Search Alerts/Recalls
|