Model Number CDS0706-XTW |
Device Problems
Break (1069); Difficult to Insert (1316); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 a break in the clip introducer and a leak.It was reported that during preparation, there was resistance felt while inserting the clip introducer (ci) into the guide catheter.A leak was then observed on the stopcock that was attached to the ci.It was then observed a part of the stopcock that was attached to the ci had broken off.Therefore, the clip delivery system (cds) was not used and was replaced.It was noted the sgc was continued to be used without further issues.There was 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 that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, a cause of the reported break (ci flush port) could not be determined.The reported leak was due to the reported broken ci flush port.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Event Description
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Subsequent to the previously filed report, the mitraclip xtw was fully inside the clip introducer (ci) while inserting.The issue occurred just prior to insertion.The broken stopcock attachment site was broken halfway through the introducer attachment.
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Search Alerts/Recalls
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