Catalog Number SGC0702 |
Device Problems
Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.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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This is being filed to report the kink in the soft tip.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.The steerable guide catheter (sgc) was advanced to the right atrium (ra); however it was difficult to advance the sgc through the septum.Imaging revealed the sgc soft tip kinked therefore it was removed and replaced with a new one.Two clips were implanted reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lots and a review of the complaint history identified no similar incident reported from this lot.Based on this information a cause for the reported failure to advance issue could not be determined.Additionally, reported kink on soft tip appears to be a cascading event of failure to advance.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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