(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified 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 incidents reported from this lot.All available information was investigated and the reported torn sgc soft tip appears to be related to procedural conditions and a secondary effect of the clip becoming caught on the tip during removal.There is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system is filed under a separate medwatch report.
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This is filed to report the steerable guide catheter (sgc) soft tip tear.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The clip delivery system (cds) was advanced to the left atrium; however, while steering with the m-knob, the cds was steering in an unintended direction.The cds was attempted to be removed, but became caught on the sgc soft tip.Force was used and the clip was freed from the sgc tip.It was determined that the blue alignment markers had not been confirmed to be aligned.One clip was implanted, reducing the mr to 1.After removal of the sgc, it was found that the soft tip was torn.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.
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