It was reported that during a cryo ablation procedure, the patient's blood pressure was not as expected requiring vasopressors to be administered.The patient went into ventricular tachycardia (vt) multiple times.It was observed on the intra-cardiac echocardiogram when the epinephrine took effect, the heart started beating rapidly prior to going into vt.Cardioversion was attempted four times.After the fourth shock was given, the patient went into ventricular fibrillation (vf).Compressions were initiated.Post code, a cardiac catherization was performed and the coronary arteries were found to be clean.The patient had a heart pump placed and sent to the intensive care unit (icu).The case was aborted under general anesthesia.No further patient complications have been reported as a result of this event.
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Product event summary: the data files and the afapro28 balloon catheter with lot number 14918 were returned and analyzed.The patient files showed at least four applications were performed with the balloon catheter without any issue on the date of the event.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for four applications on the reported event date.The catheter was recognized and passed the electrical integrity verifications and performance test.The catheter completed the inflation, ablation, and thawing phases with no system notices generated.No performance issues were identified.All temperature, pressure, and flow were in range without any oscillation or overshoot.In conclusion, the clinical issues (arrhythmia, hypotension) occurred during the procedure and death occurred a day after the procedure.The case was aborted under general anesthesia.There is no indication of a relation of the adverse event to the performance or malfunction of the product.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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