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It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest requiring surgical intervention.It was reported that during a procedure, when the decanav catheter was plugged in and ready to enter the body, is when a "catheter sensor error" message was displayed on the carto 3 system.They reported that the catheter was unable to be visualized.To troubleshoot, the cable was replaced without resolution.The catheter was replaced, the issue was resolved and the procedure was continued.It was also reported that during the same procedure, an adverse event was reported.They also reported that further into the case 4 biosense webster catheters were in the body.They went to map the right atrium and they were preparing to go transseptal, the patient's heart rate dropped to zero and they went into cardiac arrest.They reported that no pericardial effusion was observed; however, there was an st elevation that was noted after cardiopulmonary resuscitation (cpr) was performed and rhythm was restored.They were unsure of what led to the event.The patient's coronary arteries were checked after the patient was stable and there was no occlusion at that time.They noted that the patient was asystolic and needed compressions for a while.A coronary angiogram and cpr were both performed.The anesthesia was also used to chemically support the patient.The patient is now stable.During the time of the event, an ablation catheter, an s-curve navigation catheter, a vizigo sheath, and a reprocessed soundstar catheter were in the body, however, none could be exclusively linked to the adverse event.No clinical study was being conducted.Additional information was received.There were biosense webster catheters in use when the adverse event occurred.They were mapping the right atrium and had not performed any ablations.Physician¿s opinion on the cause of this adverse event was that it was believed to be procedure related but unsure.Patient required extended hospitalization because of the adverse event as the patient remained in the hospital and ultimately received an icd implant.Other relevant history -patient appeared to have a patent foramen ovale (pfo).Since the adverse 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.This adverse event was assessed as mdr reportable under the thermocool® smart touch® sf bi-directional navigation catheter.The catheter sensor error issue was assessed as non mdr reportable.The incidence of magnetic sensor error is easy detectable by the user.The catheter is inoperable, since it cannot be visualized on the carto system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.
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The bwi product analysis lab received the device for evaluation 28-feb-2023.The device evaluation was completed on 03-mar-2023.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 and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.Physician¿s opinion on the cause of this adverse event was that it was believed to be procedure related but unsure.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 instruction 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.Manufacturer's reference number: (b)(4).
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