Catalog Number CDS0706-XTW |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
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Event Description
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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and a flail.An xtw clip was inserted, and during grasping while simultaneously and independently actuating the grippers, one of the grippers would not lower.Troubleshooting was performed, including locking and unlocking the clip, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.The procedure was continued, and a new xtw clip was successfully implanted, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.
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Manufacturer Narrative
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All available information was investigated, and the reported single gripper actuation issue was confirmed via returned device analysis.Additionally, the harness was observed to be jammed and the gripper cover was observed to be bulky.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 complaints reported from this lot.Based on available information and the returned device analysis, the cause of the reported single gripper actuation issue and pinched harness cannot be determined.The observed bulky gripper cover is a cascading event of the reported jammed harness.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.
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Search Alerts/Recalls
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