Catalog Number CDS0706-XTW |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
Event Type
Injury
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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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Event Description
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It was reported this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted and placed on the mitral valve.However, when unwinding the lock line from the lock lever, it was observed the lock line was knotted.The knots were unable to be removed and the lock lines were tangled around the lock lever; therefore, the physician decided to cut the lock lines.The lock line was then able to be removed and the clip was successfully implanted, reducing mr to a grade of 1.There was no clinically significant delay in the procedure.No additional information was provided.
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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 the reported event.A review of the complaint history identified no similar complaints from the lot.Based on the information reviewed, the reported lock line knot (material deformation) resulting in difficulty removing the lock line appears to be related to user technique of unwrapping/removal of the lock line.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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