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Catalog Number SGC0705 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 01/23/2024 |
Event Type
Injury
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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 reported soft tip deformation and tissue injury were unable to be determined.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment 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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Event Description
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It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3-4 and thin leaflets.A steerable guide catheter (sgc) was inserted without issues, but while passing through the fossa, tissue was observed at the tip of the sgc.Per physician¿s instructions, the procedure was continued with the tissue as it was.The procedure was completed with one clip implanted, reducing the mr to a grade of 1.After the sgc was removed from the patient, it was observed that less than 1mm of tissue was on the sgc, a foreign object was on the tip of the sgc, and a tear was on the soft tip of the sgc.It was noted that there was no tear during system prep.There was no clinically significant delay in the procedure.
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Manufacturer Narrative
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All available information was investigated, and the reported deformed sgc tip 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 available information, the reported soft tip deformation and tissue injury were unable to be determined.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: code 4755 removed.
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Search Alerts/Recalls
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