Model Number 7132 |
Device Problem
Break (1069)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/14/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: used (b)(6) 2019 as the provided event date was (b)(6) 2019.
|
|
Event Description
|
It was reported via medwatch that a shaft break occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm emerge balloon catheter was selected for use.However, while advancing the device the balloon catheter snapped.No known patient complications were reported.
|
|
Event Description
|
It was reported via medwatch that a shaft break occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm emerge balloon catheter was selected for use.However, while advancing the device the balloon catheter snapped.No known patient complications were reported.It was further reported that the 80% stenosed target lesion was located in the severely tortuous and severely calcified ostial right coronary artery.The device broke after the monorail and was completely removed through a normal method.The procedure was completed with another 2.50mm x 12mm emerge balloon catheter and the patient did well.
|
|
Manufacturer Narrative
|
Date of event and describe event or problem updated.
|
|
Search Alerts/Recalls
|