Catalog Number CDS0706-XTW |
Device Problems
Mechanical Jam (2983); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
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.
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Event Description
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It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr) with a grade of 4, rotated heart, and hiatal hernia.A mitraclip xtw was inserted and placed on the mitral valve, but while attempting to deploy the clip, the lock line became stuck.Resistance was encountered after retracting the clip approximately 10 inches.The clip was unlocked and was removed from the patient.Another mitraclip xtw was implanted.The procedure was complete with one clip implanted.The mr was reduced 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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All available information was investigated and the reported inability to remove the lock line was 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 determined the reported inability removing the lock line was due to the observed knot in the lock line; however, a definitive cause for the knot cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.H6: code 4012 removed.
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Search Alerts/Recalls
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