Catalog Number CDS0705-NTW |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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The clip remains in the patient.The device will not be returned for evaluation.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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It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr) and a prolapsed posterior leaflet for a mitraclip procedure.The physician believes the screws on the delivery catheter (dc) fasteners are not tight enough.The procedure was completed without any problems using the original fastener.Comparing the shape of the tip with the long fastener for the stabilizer, the fastener on the dc handle is rounder.The dc handle did not have the same amount of resistance as normal and rotation felt looser.The dc handle was operated carefully and held to prevent rotation during the procedure in a preventive and safe manner.There was no malfunction or unintended movement.The physician pointed out that he was able to move more easily than normal in the rotational direction.He suggested that the shape of the screw tip (e.G., square or round) can affect mobility.The mr was reduced to grade 1.There were no adverse patient effects or clinically significant delay.
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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, the cause of the reported unstable dc fastener was unable to be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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