Model Number CDS0601-XTR |
Device Problems
Difficult to Open or Close (2921); Unintended Movement (3026)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional two devices referenced are filed under separate medwatch report numbers.
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Event Description
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This is being filed to report the clip jumping during device preparation.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.During preparation of the clip delivery system (cds) it failed to establish final arm angle (efaa) and the clip jumped open; therefore the cds was not used in the procedure and there was no patient involvement.Two additional cds were inserted into the patient however per the physician, they did not perform as intended therefore the clips were not implanted and the cds removed.Three clips were implanted, reducing mr to 3-4.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 for analysis.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 identified no other incidents reported from this lot.All available information was investigated and the reported the reported unintended movement and difficult to open or close could not be determined in complaint.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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