Catalog Number SGC0302 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 11/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The customer reported the sgc was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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This is filed to report cardiac arrest.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing the mr to 1-2.During removal of the steerable guide catheter (sgc), the patient suffered a cardiac arrest.After removal of the sgc, it was noted that one of the pacemaker electrodes was moved out.In the physicians opinion, the manipulation of the sgc and heart morphology may have contributed to the cardiac arrest.The patient was stabilized with an electro-catheter and will remain hospitalized awaiting another interventional procedure to replace the electro catheter.One clip was implanted, reducing mr to 1-2.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.All available information was investigated, and the reported device causing damage to another device appears to be due to a combination of user technique of sgc retraction during the procedure, and the rotated heart and dilatation of cavities.The reported cardiac arrest was a cascading effect of the reported device causing damage to another device, as the patient experienced cardiac arrest immediately after the pacemaker electrode was dislodged by the sgc.The reported patient effect of cardiac arrest is listed in the mitraclip nt system instructions for use as a known possible complication associated with mitraclip procedures.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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Subsequent to the initially filed report, the following information was received: the steerable guide catheter (sgc) had interacted with the pacemaker.No additional information was provided.
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Search Alerts/Recalls
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