Catalog Number SGC0302 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/12/2020 |
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 deformation to the soft tip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter was prepped and inserted; however, during advancement, the soft tip of the sgc became damaged and was no longer circular.The sgc was removed and it was noted that no damage occurred to the anatomy.A new sgc was used and two clips were 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.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated and a cause for the deformation due to compressive stress associated with the soft tip deformation cannot be determined.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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