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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
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It was reported that a 49-year-old female patient (bmi ~30) underwent a right atrial tachycardia (at) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the patient suffered a pericardial effusion / cardiac tamponade diagnosed two hours post-ablation.During the right atrial tach ablation, the physician was mapping and ablating in the coronary sinus osteum, where the impedance was fluctuating from 120-300 ohms on the smartablate generator, variation with respiration and cardiac motion.The generator would not allow ablation over 250 ohms, as this was the default cut-off setting.The physician then asked the caller to remove the impedance spike cut-off and max impedance cut-off settings.Ablation was continued.The patient took a deep breath and shortly thereafter complained of chest pain, so the physician ordered heavier sedation to have the patient asleep for the procedure.While the thermocool® smart touch® sf bi-directional navigation catheter was in the inferior vena cava (ivc) region, the catheter icon appeared as if in the liver, the force vector was pointing upward, and the force value was high, 60 grams and no cardiac signals.The physician believed this force value to be incorrect (caller stated earlier in the case they had to switch out an thermocool® smart touch® sf bi-directional navigation catheter because of a force error).The physician pulled the catheter back and redirected into the area of interest and the force value was lower.The ablation was continued to completion.Two hours later, while the patient was in recovery, they were complaining of tight chest pain, spreading up into the neck.A transthoracic echo revealed a pericardial effusion around the left and right ventricles.There were no ekg or blood pressure changes.Another physician was called to perform a pericardiocentesis in the recovery bay.Patient status was unknown to caller, they were not given updates as they were mapping in a different procedure.The physician did not indicate that they believed biosense webster, inc.Products contributed to the patient's event.Additional information was received.Intervention provided was minimal fluid drain of 100cc.The patient outcome of the adverse event was fully recovered.The patient required extended hospitalization because of the adverse event, patient went home the next day (overnight stay).A baylis needle with unknown catalog was used.No steam pop.Standard smart touch sf flow settings were used: 7 low and 15 high.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Graph; dashboard; vector; visitag force visualization features were used.The visitag module was used, parameters for stability used were recommended tag settings (2.5mm, 3s, 25% fot, 2mm tag size).No additional filter was used with the visitag.Impedance color option was used prospectively.The physician had bs ekg 12 lead signal available to monitor patient heart rhythm.During the signal loss issue, the affected catheter was not inside the patient¿s body.It was assessed that ¿prolonged hospitalization¿ will not be coded as the patient only had an overnight stay.Since the adverse event was life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The force high issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.The high impedance issue was assessed as not mdr reportable.Since the user-defined cut-off was exceeded and ablation was stopped, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The visualization issue was assessed as not mdr reportable.The device is not visualized by the carto system.The user will have to replace the catheter in order to complete the case.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The signal issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.
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Additional information received on 23-sep-2022.No signal losses were observed during the procedure.Therefore, removed under h6.Medical device problem code of ¿ signal artifact (a090801)¿.The device evaluation was completed on 15-oct-2022.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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