Model Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Heart Block (4444)
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Event Date 05/30/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a heart block av requiring surgical intervention for pacemaker implantation.It was reported that after cardiac isthmus (cti) for atrial flutter (afl), complete atrioventricular block (cavb) occurred during ablation for atrial tachycardia (at).Event occurred between creation of cti and cessation of atrial tachycardia.After cavb, when the heart rate was in the 40s, the temporary pacemaker was implanted and the patient exited the room.The physician¿s assessed the health problem as non-serious.The physician's opinions on the relationship between the event and the product was unknown because the patient had been receiving ¿maintate¿ at the time of the procedure, therefore, it was considered that the cavb have developed and would return to normal over time.There were no abnormalities observed prior to and during use of the product.A smartablate generator was used in this case.Methods of contact force (cf) monitoring used included dashboard; vector and visitag.Visitag color settings include tag index.
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Manufacturer Narrative
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On 24-jun-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent an atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a heart block av requiring surgical intervention for pacemaker implantation.It was reported that after cardiac isthmus (cti) for atrial flutter (afl), complete atrioventricular block (cavb) occurred during ablation for atrial tachycardia (at).Event occurred between creation of cti and cessation of atrial tachycardia.After cavb, when the heart rate was in the 40s, the temporary pacemaker was implanted and the patient exited the room.The physician¿s assessed the health problem as non-serious.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.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 physician's opinion on the relationship between the event and the product was because the patient had been receiving maintain at the time of the procedure, it was considered that the cavb have developed and would return to normal over time.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Search Alerts/Recalls
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