Model Number 001-700-001MI |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/30/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4) the device has not yet been received by atricure.When additional information is received a supplemental report will be submitted.
|
|
Event Description
|
During a off-pump cardiac ablation procedure, the magnet from the fusion magnet retriever got loose at the end of the procedure.The case was completed without any delay and patient outcome was not affected.
|
|
Manufacturer Narrative
|
(b)(4).The device was returned to atricure and pursuant to (b)(4) and was visually and functionally tested.The magnet housing on the swivel positioner had failed allowing the magnet to become dislodged from the housing.The magnet was not returned with the device.The complaint was confirmed.
|
|
Search Alerts/Recalls
|