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It was reported that a patient underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac arrest and cardiac tamponade requiring pericardiocentesis.It was reported that a cardiac perforation and pericardial effusion were noticed while performing a post-voltage map after ablation had been completed.They reported that the patient's blood pressure dropped from the mid-70s to the mid-60s.When the physician tried to palpate the patient's pulse, the physician was unable to find anything.The injury was confirmed with an intracardiac echo.Pericardiocentesis was performed and 530 ml of fluid was removed.The patient was reported to be in stable condition.The physician believed that the injury may have occurred during the transeptal puncture.The patient had hypertrophic cardiomyopathy and distorted anatomy.Additional information was received.The event was noticed after the use of bwi product.They had finished the pvi and noted the effusion after pulling back into the right atrium.The physician believed that due to the patient's hypertrophic cardiomyopathy, the oversized lv distorted the rest of the anatomy making transseptal difficult.She said that it could not have been due to the catheters (ice, abl, decanav or octaray) as the effusion was very slow.Roughly 10 mls every 5 minutes.Initially cpr was performed to get the patient hemodynamically stable which was followed immediately by a pericardial tap to drain the build-up of fluid.The patient recovered well enough to be transferred to the intensive care unit (icu) for extended monitoring.The drain was left in place just in case which required an extended stay and additional monitoring in the cardiac icu.No relevant history other than hypertrophic cardiomyopathy and atrial fibrillation.Transseptal puncture was performed using an abbott sl1 and a baylis nrg transseptal needle.Rf energy was used for the puncture using the baylis generator (1 second pulse).No effusion was noted at baseline.The pvi was performed and upon pulling back into the ra, the effusion was discovered.There was no evidence of a steam pop.The physician believed the event occurred during the transseptal puncture.A smart touch sf catheter was used for the procedure.Irrigation was set per the ifu of 8/15 ml/min with a 3 second pre and 3 second post flush.They ablated at 30 to 40 watts depending on if we were anterior or posterior.The catheter was flushing at 15 ml/min the entire time.Smart touch sf was selected on the generator.The pump was switching correctly.There were no error messages on the carto 3 system during the case.All force visualization features were used.Ablation parameters were respiratory gated 2.5mm, 3 seconds, 25% 3 grams with a tag size of 3mm.Distance between lesions is typically less than 5mm.No additional filter was used for the visitags.Tag index was used for the color options.
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The bwi product analysis lab received the device for evaluation on 03-apr-2023.The device evaluation was completed on on (b)(6) 2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The physician believed the event occurred during the transseptal puncture.A smart touch sf catheter was used for the procedure.Irrigation was set per the ifu of 8/15 ml/min with a 3 second pre and 3 second post flush.They ablated at 30 to 40 watts depending on if we were anterior or posterior.The catheter was flushing at 15 ml/min the entire time.Smart touch sf was selected on the generator.The pump was switching correctly.There were no error messages on the carto 3 system during the case.All force visualization features were used.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number:(b)(4).
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