It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr) for a mitraclip procedure.During lock line removal, the cap and o-ring were carefully removed.Both ends of the lock line were held during initial unwrapping and it was flossed as normal.There were no knots observed.The lock line was retracted approximately 4 or 5 inches, when the jam occurred.The other end could not be seen.Troubleshooting, such as; loosening the arm positioner and attempting to reduce angulation with m knob was performed.It was decided to remove the clip and clip delivery system (cds).The lock lever cap was replaced, the clip was unlocked, opened, and inverted to the left atrium.The cds and clip were removed safely.A replacement was used to complete the procedure.There was a delay, but no adverse patient effects were reported.No additional information was provided.
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All available information was investigated and the reported mechanical jam of inability to remove the lock line was not confirmed via returned device analysis.A review of the lot history record revealed 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 complaints reported from this lot.The investigation was unable to determine a cause for the reported inability to remove the lock line.There is no indication of a product issue with respect to manufacture, design, or labeling.
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