Model Number CDS0701-NTW |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/05/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
This is filed to report the gripper line breaking.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted, and the clip was placed on the valve.However, the gripper line broke while attempting to remove.Therefore, the clip was removed without issues and was replaced.One clip was deployed, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information and without the device to analyze, the cause of the reported broken gripper line was unable to be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|
|