This is filed to report that during advancement of the steerable guiding catheter (sgc), the sgc became stuck.After removal, the sgc soft tip was damaged.Difficult to remove has the potential to cause or contribute to patient injury.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.During insertion of the steerable guiding catheter (sgc), the wire kinked due to the narrow vessel.The sgc could not be advanced and became stuck due to resistance with the anatomy and the guide wire.Force was used to advance the sgc, and the tip of the sgc was stressed.After multiple attempts to advance, the sgc was removed for visual inspection.During removal, resistance was again noted.There was strong bending observed, and the tip of the sgc was bent.The device was replaced, and a new sgc was used to continue the procedure.Two clips were implanted, reducing the mr to <1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.The mitraclip instructions for use- steerable guide insertion states the following warning: do not use excessive force to advance or manipulate the guide-dilator assembly.If resistance is encountered, use echocardiography and/or fluoroscopy to assess before proceeding.All available information was investigated and the reported failure to advance the steerable guiding catheter (sgc) appears to be related to challenging vessel anatomy.The reported bent sgc shaft, resulting in difficulties removing the device, appears to be a result of user error.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
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