(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: all available information was investigated and the reported kinked steerable guide catheter (sgc) tip was confirmed.The returned device analysis confirmed the reported kinked sgc tip as the soft tip circumference was not rounded.The investigation also observed that the soft tip was torn.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation concluded that the torn and kinked soft tip was due to the clip getting caught on the tip of the sgc.There is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system referenced is filed under a separate medwatch report number.
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This is filed based on returned device analysis which found that the steerable guide catheter (sgc) soft tip was torn.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The clip delivery system (cds) was advanced to the mitral valve; however, the cds was inadvertently advanced too far.The cds was retracted back when the clip got caught on the tip of the sgc.The sgc tip became kinked.The clip was not implanted and both devices were removed together and replaced.The procedure was successfully completed with a new sgc and a new cds.Three clips were implanted, reducing mr to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis found that the sgc soft tip was torn.No additional information was provided.
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