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Model Number SGC0701 |
Device Problems
Break (1069); Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Event Description
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This is filed to report the sgc cable break.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.The steerable guide catheter (sgc) was advanced without issue and during the procedure, the physician commented that +/- knob was not responding as normal and that there was a lack of resistance while the knob was rotated.However, the clip was implanted without issue, reducing mr to 1-2.After the sgc was removed, the physician was testing the knob and over manipulated the knob that the cable broke.There was no adverse patient effect 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 other complaints reported from this lot.The investigation was unable to determine a cause for the reported unstable knob (knob was not responding as normal and that there was a lack of resistance).The broken cable was due to user technique.There is no indication of a product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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