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Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on (b)(6) 2022.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 4.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 66 year old male patient underwent an unknown procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade.It was reported that after the left atrial approach was made with the thermocool® smart touch® sf bi-directional navigation catheter, the contact force (cf) display turned to high in the middle of the procedure.If zeroing was performed even in a place where there was no interference with other catheter or atrial walls, display was not turned to 0, but immediately became hi.The issue was not resolved despite performing zeroing at outside of the patient's body.Because the cable was new, the catheter was suspected that the cause.The timing when complaints occurred was about 20 minutes after the start of use.The issue was resolved by changing the thermocool® smart touch® sf bi-directional navigation catheter to another one.Cardiac tamponade occurred.There were abnormalities observed during use of the product.Additional information was provided.The force visualization features used were real time graph; dashboard and vector.The adverse event was assessed as mdr reportable.Since the event was 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 was to be considered serious and mdr-reportable.The force high issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.
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It was reported that a 66 year old male patient underwent an unknown procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade.It was reported that after the left atrial approach was made with the thermocool® smart touch® sf bi-directional navigation catheter, the contact force (cf) display turned to high in the middle of the procedure.If zeroing was performed even in a place where there was no interference with other catheter or atrial walls, display was not turned to 0, but immediately became hi.The issue was not resolved despite performing zeroing at outside of the patient's body.Because the cable was new, the catheter was suspected that the cause.The timing when complaints occurred was about 20 minutes after the start of use.The issue was resolved by changing the thermocool® smart touch® sf bi-directional navigation catheter to another one.Cardiac tamponade occurred.There were abnormalities observed during use of the product.The device evaluation was completed on 17-nov-2022.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested.The temperature and impedance values were correctly displayed and the device was properly recognized and visualized.No electrical issues were observed either.However, error 106 was displayed due to an open circuit in the tip area.In addition, the product was deflecting and irrigating correctly.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The force issue reported by the customer was confirmed, as error 106 could be related to the force issue experienced by the customer.It should be noted that product failure is multifactorial, the instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.The root cause of the adverse event remains unknown; 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 instructions 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.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿adverse event¿ issue.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported ¿force high¿ issue and the biosense webster inc.Product analysis lab noted the ¿open circuit in the tip area¿.Additional information was received on 02-dec-2022.The adverse event was discovered post use of biosense webster products.The cause of this adverse event is unknown.Drainage was performed.The patient recovered and has already been discharged from the hospital.Patient did not require extended hospitalization because of the adverse event.Smartablate generator was used, the serial number was unknown.Brockenbrough was performed.Jll rf needle (nrg rf transseptal needle) was used.Ablation was performed prior to noting the cardiac tamponade.No evidence of steam pop the adverse event was confirmed in the ward after the procedure.The flow setting for the irrigated catheter used was 15ml/min (pre:2sec, post:5sec.Correct catheter settings was selected on the generator.The pump flow setting was normally controlled by the generator.No error messages observed on biosense webster equipment during the procedure.Parameters for stability for the visitag module used was 3mm, 3sec, 25%, 2mm tag.Additional filter used with the visitag was respiration.Color options used prospectively was tag index: low: 350, high: 400.Therefore, updated d10.Concomitant medical products and therapy dates field.In addition, the physician information was received.Therefore, updated e.Initial reporter section.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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