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Catalog Number SGC0705 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 12/16/2022 |
Event Type
Injury
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Event Description
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This is filed to report a cardiac tamponade requiring intervention.It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4+.The transseptal puncture was challenging due to the rotated heart and visualization of the septum was also challenging.After steerable guide catheter (sgc) and clip delivery system (cds) insertion through the septum, m-knob was used to steer down to the valve, but they realized that the height of the transseptal puncture was not adequate enough.All troubleshooting steps to overcome the height were performed but there was still issues of height and aorta hugger.The team decided to remove the devices and re-puncture the septum.The second puncture was attempted at least five times to obtain a good tenting and height, but due to difficult images and the needle jumping from the thick part of the septum to the inferior part of the fossa, they could not gain enough height.The decision was made to abort the procedure.After the procedure, the patient developed cardiac tamponade and needed a drainage procedure.After the drainage the patient was recovering well and stable.According to the physician it is unknown when the tamponade occurred and what caused it.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.Based on available information, the reported image resolution poor was associated with difficult visualization.The cause of the reported cardiac tamponade (pericardiocentesis) could not be determined.The reported patient effect of cardiac tamponade, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results 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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N/a.
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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.Based on available information, the reported image resolution poor was associated with difficult visualization.The cause of the reported cardiac tamponade (pericardiocentesis) could not be determined.The reported patient effect of cardiac tamponade, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H10: manufacturer complaint investigation summary was corrected.
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Search Alerts/Recalls
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