All available information was investigated, and the reported inability to curve the distal tip with the m/l knob and cable break were confirmed, as the ¿m¿ cable was noted to be broken at the radiopaque tip ring.Additionally, it was identified that the tip was unable to straighten with the m/l knob.The reported noise could not be replicated in a testing environment.The reported physical resistance/sticking of the knob was not confirmed.A review of the lot history record revealed 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 the information provided and analysis of the returned device, a cause for the reported knob resistance could not be determined.However, the investigation determined the reported/observed m-cable break resulting in noise and positioning failure of inability to curve and straighten the tip with the m/l knob as a potential product issue.The investigation evaluated the reported issue, and the engineering group found the investigation to be inconclusive, as the investigation was unable to confirm root causes related to design, labeling, or manufacturing.However, a potential contributing factor though not confirmed was determined to be method.The issue is being addressed per internal operating procedures.Additionally, it was confirmed that the calculated occurrence risk level is within the expected rate per the risk assessment.Abbott will continue to trend the performance of these devices.
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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was observed that the m-knob was broken and unable to curve.Therefore, the clip was removed and replaced.One clip was then successfully implanted, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.
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