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Catalog Number SGC0701 |
Device Problems
Break (1069); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2023 |
Event Type
malfunction
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Event Description
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This is filed to report a cable break.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.A noise was heard when a steerable guide catheter (sgc) was advancing into the left atrium and while applying minus knob.It was suspected a cable break occurred.Therefore, the sgc was removed and replaced.A new sgc was used, and the procedure was continued.One clip was successfully implanted, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for 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.Based on available information and without the device to analyze, the reported noise, audible (noise) was due to the suspected cable break.The cause of the reported suspected break (cable break) could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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