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E1.Initial reporter phone:(b)(6).It was indicated that the device is not available for return; therefore, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31215218l and no internal action related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 patient underwent an atrial fibrillation ablation which included the use of a thermocool® smart touch® sf bi-directional navigation catheter and during ablation phase, the patient experienced cardiac tamponade that required pericardiocentesis and drain placement.It was reported that ten (10) minutes after posterior wall isolation, two and a half (2.5) hours after the start of the procedure was when the adverse event occurred.Superior vena cava (svc) sinus mapping was performed in ¿paf 2nd procedure¿.Before septal puncture, pericardial effusion was confirmed by sound echocardiography.Preoperative ct had shown fluid accumulation.Septal puncture, left atrial (la) pre-mapping were performed, and rabonar was administered for ¿dc¿.At that stage, systolic blood pressure was around 100 mmhg.After performing box isolation of the posterior wall, fluoroscopy showed that the heart was not moving well, and a sound echocardiogram also showed pericardial effusion.Although it was not clear whether there was a decrease in blood pressure or an increase in pericardial fluid, cardiac drainage was performed, and about 200 ml of blood-like pericardial fluid was withdrawn.The operation of the brockenbrough (bb) was not particularly uncomfortable, and the contact force (cf) during ablation was 10-15g, with no obvious periods of high cf.The procedure was completed.The blood pressure stabilized around 120/80 mmhg.Ablation was performed prior to the cardiac tamponade identified.Steam pop was not observed.The physician considers that it was unclear whether it was caused by the ablation.No abnormalities were observed prior to or during use of the product.Additional information was received which indicated that the patient's progress was uneventful, and pericardial drainage was removed the next day.After the treatment, a computed tomography (ct) scan was performed and confirmed that there was no pericardial effusion.Patient improved.No error messages were observed on bwi equipment during the procedure.The physician considers that it was unclear whether it was caused by the ablation.Pericardial effusion was also found prior to the procedure, and it was unclear whether it was increased during the procedure or not, so it was unknown if the issue was related to the procedure.The physician recognized that there were no problems with the ablation procedure, including high cf or increased/decreased impedance, or septal puncture and other techniques.The patient fully recovered.The patient's progress was uneventful, and the pericardial drain was removed the day after procedure, and the patient was discharged from the hospital on march 23rd.The patient did not require extended hospitalization.
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