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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.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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It was reported that a patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident.It was reported that the impedance readings for the ablation catheter were steadily rising during ablation in the left atrium, 45 watts used on the anterior wall.They informed the physician, ablation was stopped, and the catheter was removed from the body.The physician noted "quite a bit" of char on the catheter.The catheter setting was confirmed correct (tc sf) on the smartablate generator.The catheter was replaced, and the procedure continued.About 30 minutes later, while the patient was in post-procedure recovery, the patient was diagnosed with a stroke.This was confirmed by ct scan and neurology consult.The patient is currently undergoing a procedure to address the stroke.The adverse event was discovered post-use of bwi products.They stated that the md thinks it may be due to the char on the ablation catheter.Patient required extended hospitalization because of the adverse event as the patient had a stroke.Transseptal puncture was performed with a versacross.Prior to noting the pe or ct, ablation was performed.No evidence of steam pop.Patient was diagnosed in post-procedure recovery room.The flow setting of irrigated catheter was md preference: 15 ml/min regardless of wattage used.No error messages observed on biosense webster equipment during the procedure.Other bwi products used was octaray, vizigo.The ablation catheter will be returned for analysis.No replacement requested.The account has not requested smartablate generator evaluation.It was also reported that the smartablate foot pedal lost connection to the generator intermittently.The procedure was continued with the issue.They were unable to provide lot number as staff had thrown away packaging prior to event.The adverse event occurred on (b)(6) 2023.Physician believes char dislodgement from catheter could possibly be cause.A thrombectomy was performed at secondary hospital.Outcome of the adverse event was unchanged, patient is stable but as of (b)(6) 2023.Was still unable to move right side of body or speak.Generator information was a smartablate systems rf generator.Ref: (b)(4), sn: (b)(4).No service needed.An attempt will be made to retrieve the carto file and share it impedance cutoff was exceeded after catheter was replaced and the system stopped the ablation when the cut off value was exceeded.Not necessary for the user able to stop the ablation using the ¿stop¿ button as system stopped the ablation.The system did not continue to ablate above/ below impedance cut-off value.Generator parameters was a power control mode.Temperature cut off was set for warning at 37 degrees and cut off at 40 degrees.Impedance cut offs were set at max cutoff: 250 ohms, spike cut off 30 ohms, and min cut-off 50 ohms.Temperature was noted as normal since it did not trigger any alerts.Impedance values.Power was set for 45 watts when rising impedance values were noted.Serial # of the generator used during the procedure was sn: (b)(4).Doctor did not specific where char was but that it was dangling off of catheter tip.The rising impedance values were noted by the bwi representative.No issues related to temperature and flow on the catheter.The patient was anticoagulated.Act¿s were maintained above 300 during duration of case.Pump information was a smartablate systems pump sn: (b)(4).Duration of the ablation was determined when a targeted surpoint value was achieved so there was duration variability.Average contact force varied as well, but was consistently over 20 grams.They did not note any ablations that used force above 40 grams for an extended period of time.Irrigation rates of 15 ml/min was used for both above and below 30 watts.The pre-ablation high setting was the default 2 ml/min.Heparnized normal saline was used as the irrigation fluid.Carto visitag module was used, respiration setting was end expiration, stability range and time: 3 mm for 3 seconds, fot: 25% and tag size 3mm.The foot pedal did not get stuck and continue ablating.When pressed an error message would pop up saying there was no connection between the foot pedal and the remote.The distance between the remote and the closest magnet was roughly 2-3 feet.Char is not mdr-reportable.High impedance cut-off exceeded is not mdr-reportable.Since the event 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 and mdr-reportable.
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On 25-may-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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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