Catalog Number CDS0706-XT |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2024 |
Event Type
malfunction
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Event Description
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It was reported that during device preparation, it was noted that mitraclip xt opened when the lock was tested.The arm positioner was turned one full turn from a slightly tightened position when the clip opened continuously to 60 degrees.It was noted that when the clip was locked, it could open from 1 degree to fully inverted as the arm positioner was turned.The lock did not hold with the slightest turn of the arm positioner.A new xt was used to complete the procedure.The issue device was not used in the patient's anatomy.
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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.
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Manufacturer Narrative
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All available information was investigated and the reported clip open during efaa was not confirmed via returned device 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.The investigation was unable to determine a cause for the reported clip open during efaa.There is no indication of a product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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