Catalog Number SGC0301 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
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Event Date 08/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The customer reported the device was discarded.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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This is being filed to report during the procedure when the steerable guide catheter was being advanced, the patient¿s blood pressure dropped, and experienced asystole.Therefore, cardiopulmonary resuscitation (cpr) was performed and a balloon pump was inserted.It was reported that this was a mitraclip procedure to treat a mixed mitral regurgitation (mr) with grade of 4+.When the steerable guide catheter (sgc) was being advanced, the patient¿s blood pressure began to drop and experienced asystole.The patient went into cardiac arrest which required cardiopulmonary resuscitation (cpr) and a balloon pump was inserted.Additionally, epinephrine was administered, and the patient's condition improved and stabilized quickly.The procedure was completed with one clip implanted successfully reducing mr to 1.The balloon pump was removed from the patient.After the procedure, the patient was extubated.On (b)(6) 2019, a right-heart catheterization test was performed, and the results were within range.The patient remains in the hospital.No additional information was provided.
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Manufacturer Narrative
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Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effects of hypotension, arrhythmias and cardiac arrest as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.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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