Catalog Number SGC0705 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Atrial Perforation (2511)
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Event Date 01/04/2021 |
Event Type
Injury
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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 atrial septal deviation [damage] after the sgc was removed.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.One clip was implanted, reducing mr to 1.After the steerable guide catheter (sgc) was removed, it was noted that the septum was deviated [damage].Since there was no patient sequela, the patient is under observation.No additional information was provided.
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Event Description
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Subsequent to the initial report filing, additional information reported that the patient was discharged on (b)(6) 2021.No additional information was provided.
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Manufacturer Narrative
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The device was returned.A visual and dimensional inspection was performed on the returned device.The reported failure to advance could not be tested as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported failure to advance and the subsequent treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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Search Alerts/Recalls
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