Catalog Number CDS0602-XTR |
Device Problems
Leak/Splash (1354); Unstable (1667); Material Protrusion/Extrusion (2979)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/12/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
|
|
Event Description
|
This report is filed as a leak was noted at the gripper lever cap and a small part of red gripper line was outside the lever thread.It was reported that during clip delivery system preparation, a leak was observed at the gripper lever cap.The gripper lever cap was completely closed; however, a small part of the red gripper line cover was observed outside the lever thread.The device was set aside and was not used.There was no patient involvement.No additional information was provided regarding this device issue.
|
|
Manufacturer Narrative
|
Device codes: 2979 labeled.Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents for the reported issues.In this case, the device was not returned for evaluation.However, due to the reported information that a leak was observed at the gripper lever cap and the polyimide tubing was observed to be outside the lever thread, this failure mode appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
|
|
Search Alerts/Recalls
|