Model Number FA-77400-20 |
Device Problems
Positioning Failure (1158); Activation Failure (3270)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/25/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been returned for evaluation; however, return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.
|
|
Event Description
|
Medtronic received information that the "head could not open in processing." the physician withdrew the system and used a second device and encountered the same problem.A new device was used to complete the surgery successfully.No patient injury was reported.
|
|
Manufacturer Narrative
|
The device will not be returned for evaluation.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Information received from the same report as mfr: 2029214-2016-00239.
|
|
Event Description
|
Medtronic received additional information that two devices could not be released from the protective capture coil.The pushwires were rotated no more than 10 times.The physician withdrew the systems and a new device was used to complete the procedure.No patient injury was reported.The aneurysm, located in the left ophthalmic segment of the left internal carotid artery.It was of an irregular shape with max diameter of 7 mm.The distal landing zone was 4.19 mm and the proximal was 3.8 mm.The neck was 7mm x 6mm.The patient had moderate vessel tortuosity.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|