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Model Number SGC0701 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Air Embolism (1697); Cardiac Arrest (1762); Pericardial Effusion (3271)
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Event Date 05/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional device filed under a separate medwatch report number.Na.
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Event Description
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This is filed to report leak, air embolism, cardiac arrest, pericardial effusion, pericardiocentesis, cpr and hospitalization.It was reported that this was a mitraclip procedure to treat severe degenerative mitral regurgitation (dmr).During use of the steerable guide catheter (sgc) (10204u442), the device would not hold fluid column.After drawing back on the syringe the device would lose the fluid column.Some air bubbles were seen in the anatomy and aspiration was required.The sgc was removed and replaced and again with the new sgc (lot 10217u232), fluid column was lost and aspiration was required although there were no bubbles seen in the anatomy with this device.The second sgc was removed and replaced and there were no issues with the third sgc and mr was reduced to mild.The starting mean pressure gradient (mpg) was 1 mmhg and the ending mpg was 3 mmhg.There were no adverse patient effects during the procedure; however, post procedure the patient coded and was stabilized quickly after cardiopulmonary resuscitation (cpr).There was pericardial effusion which was treated with pericardiocentesis.It is thought that a wire somewhere caused the effusion during the exchange of devices.The patient was hospitalized one additional day.No additional information was provided.
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Manufacturer Narrative
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The device as returned for analysis.During returned device analysis, the returned device analysis was unable to confirm the reported leak/splash (loss of fluid column during procedure).The discrepancy between what was reported (leak) and what was observed (no leak) is possibly due to the user technique at the account versus the 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 other incidents reported from this lot.All available information was investigated, and a cause for the reported leak in this complaint could not be determined.The returned device analysis was unable to confirm a leak.The reported patient effect of air embolism (therapy/non-surgical treatment, additional) is a cascading effect of the reported leak.Causes for the reported cardiac arrest and pericardial effusion (therapy/non-surgical treatment, additional) could not be determined.Additionally, the reported patient effects of air embolism, cardiac arrest, and pericardial effusion are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization or prolonged hospitalization and unexpected medical interventions (cpr, pericardiocentesis, and aspiration) are the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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