Model Number FA-77375-16 |
Device Problem
Delamination (2904)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/30/2016 |
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 upon removing the push wire from the plastic coil packaging, green layer coating fragments were observed detached from the metal core of the push wire.The device was not used on the patient.No patient injury was reported.
|
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
The pipeline pushwire and braid were returned for evaluation.The dispenser coil and the catheter were not returned for evaluation.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline braid was observed to be fully open with no damages.Dried blood was found on the tip coil, capture coil, and proximal bumper.The coating of the entire pushwire length was examined under the video inspection system (30x magnification) for coating integrity.Coating damage was observed at 5.0cm to 37.0cm from the proximal end.Based on the analysis findings clinical observation was confirmed.As the coating on the returned pushwire was observed to be damaged.The coating damage on the pushwire appeared to have been caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve.The torque device and rhv were also not returned for evaluation; therefore any contributing factors from the torque device/rhv valve could not be determined.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received additional information, that the device was used during the procedure.It was reported that the surgeon felt difficult pushing it up and removed from the patient.It was then noted that the green coating was observed detached from the push wire.
|
|
Event Description
|
Medtronic received additional information, that the aneurysm treated was located in the supraclinoid segment of the left internal carotid artery (ica).
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|