Catalog Number CDS0702-XTW |
Device Problems
Retraction Problem (1536); Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Event Description
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It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted and placed on the mitral valve.However, during deployment, it was noted there was some resistance while retracting the actuator knob.After retracting the actuator knob, the clip did not detach from the clip delivery system (cds).Troubleshooting was performed and the clip was successfully deployed, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.
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Manufacturer Narrative
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The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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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 complaints reported from this lot.Based on available information and without the device to analyze, the cause of the reported difficult actuator knob retraction and difficult clip deployment were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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