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It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a celsius¿ electrophysiology catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.The patient had a pericardial effusion one hour after the ablation.Pericardial drainage was provided for this patient who was still in the operating room when she woke up not feeling well.30 minutes was added after the procedure because of a pericardial drain.The patient was stable and alive.It was also reported that during ablation, while the doctor still had his foot on the pedal to ablate, the electrophysiology recording system (eprs) counted two ablations like one ablation stopped and another one resumed.The doctor didn't feel the two ablations as it probably stopped and resumed in 1 or 2 seconds.While the foot pedal was pressed, there was an indication stating that the ablation stopped, then it restarted.Also, at end of the ablation, the temperature was higher than the target value; they were on the 4ml preset.Ablation stopped because the temperature exceeded what was programmed in the generator (temperature control mode ¿ target 65°c, value observed at 72°c).During the temperature overshoot, the radio frequency (rf) power decreased.Additionally, a bit of tissue/skin/char was found at the end of the catheter which was caused by a burn.The tissue on the tip of the electrode was found during use while the pericardial drain was placed post use of biosense webster products.The physician considered the tissue/skin/char excessive based on their clinical experience.Additionally, the physician considered that the amount of tissue/skin/char /coagulum/thrombus/clot observed caused a potential risk to this patient as a pericardial effusion occurred an hour after.They completed the procedure with the initial smartablate generator.No delay during the case, but 30 minutes extra after the procedure for the pericardial drain.They did the procedure conventionally, so they didn't use carto 3 system or a pump.The system did not present any error messages.The temperature went higher than the temperature target (72°c for a target at 65°c), with the generator on temperature control mode.No irrigation for this catheter.The smartablate generator parameters were temperature control mode temperature cut off 95°c.During the adverse event the noted temperature was 72°c, power was 9w, and impedance is unknown as it was not noted/ visible at the time.The patient was anticoagulated, and it was monitored with i-stat.A transseptal puncture was performed with a baylis needle.Prior to noting the pericardial effusion ablation was performed.There was no evidence of steam pop.The event occurred during the ablation phase.An irrigated catheter was not used in the event.The patient outcome of the adverse event is fully recovered with no residual effects.The patient did require extended hospitalization because of the adverse event to monitor the pericardial effusion.The patient has not exhibited any neurological symptoms since the procedure was completed.
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Device investigation details: additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device (b)(4) number, and no internal action related to the complaint was found during the review.Initial reporter phone: (b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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On 16-may-2022, additional information was received indicating that on the electrophysiology recording system, the ablation was stopped and then resumed about 1 sec later while the doctor still had his foot on the pedal.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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