Catalog Number CDS0702-XTW |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.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 gripper line break.It was reported that during preparation of a mitraclip xtw, it was noticed that the gripper line was broken.The break was noted after removing the xtw from the device packaging and testing the grippers (grippers up).Another unit was used to carry out the procedure.There was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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All available information was investigated, and the reported broken gripper line was confirmed via returned device 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 the information reviewed, the broken gripper line appears to be related to a potential product quality issue.This issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
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Search Alerts/Recalls
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