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Model Number SGC0701 |
Device Problems
Difficult to Insert (1316); Failure to Advance (2524); 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 04/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.
Based on the information reviewed, the reported difficult to insert and failure to advance the steerable guide catheter (sgc) appear to be due to challenging patient anatomy.
The reported torn soft tip appears to be a result of the reported difficult to insert and failure to advance.
There is no indication of a product issue with respect to manufacture, design or labeling.
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Event Description
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This is filed to report a tear in the steerable guide catheter (sgc) soft tip.
It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) 4+.
During insertion of the steerable guide catheter (sgc), there was difficulty and due to the tortuosity at the groin level, the sgc was not able to advance past the iliac artery.
When the sgc was retracted, the soft tip was noted to be torn.
Therefore, a new sgc was used successfully in the procedure.
Two clips implanted, reducing mr to 1-2.
There was no adverse patient effect and no clinically significant delay in the procedure.
No additional information was provided.
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Search Alerts/Recalls
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