Model Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Rupture (2208)
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Event Date 12/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30656686l number, and no internal action related to the complaint was found during the review.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.Post procedure by more than a month the patient suffered focal inflammation of the valve which required mechanical valve replacement.There was no error message during the procedure and the physician also mentioned that there were no problems with the procedure.However, after more than one-month, focal inflammation developed in the mechanical valve.Surgical intervention performed was a mechanical valve replacement.The physician mentioned that there were no problems with the valve replacement.The patient's course was good.The physician¿s opinion on the cause of the adverse event was that it was not related with the procedure and the biosense webster inc.(bwi) product.The physician stated that perivalvular ablation was not performed.The physician also commented that the ablation procedure was unlikely to be the cause because it was performed with care.The patient outcome of the adverse event was improved with mechanical valve placement.The patient did not require extended hospitalization because of the adverse event.The procedure was a re-valvuloplasty.During the ablation procedure, contact force was monitored by real time graph, dashboard, vector and visitag with the color setting of visitag was tag index.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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Manufacturer Narrative
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Additional information was received on 4-apr-2022, the generator used in the case was a smartablate with serial number unknown.Therefore, the concomitant product section was updated.The physician¿s name was also provided.Therefore, the e1.Initial reporter title, e1.Initial reporter first name, and e1.Initial reporter last name were updated.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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Search Alerts/Recalls
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