This will be filed to report during insertion of the steerable guide catheter (sgc), the sgc was not able to advance due to vessel tortuosity.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr).During insertion of the steerable guide catheter (sgc); the sgc was not able to advance due to vessel tortuosity.When the sgc was retracted, the soft tip was noted to be squashed [smashed].A dilator was used to be able to the new sgc up to the vena cava.In addition, a thrombus was noted on the right side of the septum before crossing the sgc.The thrombus was aspirated before crossing the sgc.The procedure was completed successfully with the new sgc.One clip was implanted, reducing mr to 1-2.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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All available information was investigated, and the reported deformation due to compressive stress on the steerable guide catheter (sgc) shaft was confirmed via returned device analysis.In addition, the reported difficult to insert in the anatomy could not be replicated in the testing environment as it is related to the patient anatomy/procedural operational circumstances.Furthermore, the reported deformation due to the bend on the sgc soft tip was not confirmed for the returned device analysis.A review of the lot history identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.Based on all available information and the returned device analysis, the reported difficult to insert appears to be due to patient anatomy.Additionally, the reported bend on the curve of the shaft was a cascading effect of the reported difficult to insert.Lastly, the reported bent on the soft tip could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.
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