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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.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.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 (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient suffered cardiac tamponade requiring a pericardiocentesis, surgical intervention and prolonged hospitalization.It was reported that during an ablation of the cavo-tricuspid isthmus line, the physician stated that they heard a steam pop.They noted a dramatic increase in the impedance.They stated that about 15 minutes later, the patient's blood pressure began to drop.The physician used the intracardiac echocardiography (ice) catheter to confirm that the patient had a pericardial effusion.The physician performed a pericardiocentesis procedure.The amount of fluid pulled from the pericardial space was unknown.The cardiothoracic team was brought into the room.The cardiothoracic team opened the patient's chest cavity and stopped the bleeding.They stated that the ct team noted a perforation roughly 0.5 cm in size near the inferior vena cava and the right atrium connection.They noted that once the patient was in stable condition, the patient was moved to the or for further intervention.The max wattage used was unknown.The total lesion was unknown.The total ablation time is 33 minutes 24 seconds.The total fluid is 751 ml.The other biosense webster inc.(bwi) products used were a sterilmed reprocessed soundstar ultrasound catheter, patches, bwi stsf, bwi decanav, bwi vizigo, and bwi octaray.The adverse event was discovered during cti ablation.The physician did not state an opinion on the cause of this adverse event.Outcome of the adverse event was that the patient was stable and was moved to the operating room (or).The patient required extended hospitalization because of the adverse event.Transseptal puncture was performed.Irrigated catheter was used in the event.N error messages were observed on biosense webster equipment during the procedure.Visualization features used were dashboard, vector, visitag.The parameters for stability used were 3 mm , 3 seconds, 25% and 3 grams.Additional filter used with the visitag was surpoint, tag index.Color options were used prospectively was tag index.Carto 3 system software version 7.2.40.250.The steam occurred near the end of the cti line, which was after the af procedure.Generator parameters used was power control mode.Temp cut off and power cut off.The noted temperature, impedance and power wa: power: 40w.Impedance: 150-160.Temperature was unknown.The impedance cut-off value was not exceeded.The generator was manually stopped.Generator information was smartablate generator, --- ref: m490002, sn: (b)(6).Catheter lot number was unknown as packaging was thrown in the trash.The steam pop issue is not mdr reportable.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.The high impedance issue is not mdr reportable.Since the user-defined cut-off was not exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.Since the event (cardiac tamponade) is 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.
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) it was noted on (b)(6) 2023 that the physician's name and contact information were inadvertently omitted from the 3500a initial report # mwr-02062023-0001419319.Therefore, the e.Initial reporter section on this report has been updated.
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