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Model Number SGC0701 |
Device Problems
Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received.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 steerable guide catheter (sgc) shaft tear.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr), with an mr grade of 4+.When inserting the steerable guide catheter (sgc), into the groin resistance was felt, and the sgc kinked at the distal shaft.The sgc was removed without issue.There was a tear exposing the metal at the location of the kink.A new sgc was used without issue.One clip was implanted, reducing mr to 1+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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The device was returned and investigated.The reported torn and kinked steerable guide catheter (sgc) distal shaft was confirmed via returned device analysis.The returned device analysis could not replicate the reported difficult to insert in a testing environment as it is related to patient anatomy or procedural/operational circumstances.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.Based on available information, a cause for the reported difficult to insert could not be determined.The observed torn and kinked sgc distal shaft appears to be related to a potential product quality issue.This issue is being addressed per internal operating procedure.Abbott will continue to trend the performance of these devices.
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Search Alerts/Recalls
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