Model Number SGC0701 |
Device Problems
Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.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 kink in the soft tip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3.The steerable guide catheter was inserted into the femoral vein however it was difficult to advance up to the inferior vena cava (ivc).It was noted on fluoroscopy that the guide tip and dilator had folded onto themselves.The sgc was pulled back and straightened and then removed from the patient.A kink was noted in the sgc soft tip.The sgc was replaced, and 1 clip was implanted reducing the mr to a grade of 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 not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lots that would have contributed to this event and a review of the complaint history identified no similar incident reported from this lot.Based on available information, the reported kink appears to be due to reported failure to advance.The reported failure to advance was due to challenging patient anatomy.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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