Catalog Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)
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Event Date 03/29/2024 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced arrhythmia and hypotension which required surgical intervention.The loss of the p wave and the associated junctional beat were confirmed.After superior vena cava (svc) ablation, and after the catheter was removed from the patient¿s body, during hemostasis, the physician noticed a loss of p wave.When the patient entered the room, and during pulmonary vein isolation (pvi), svc ablation, there had been no problem with the p wave.After the procedure, coronary angiogram (cag) of the right coronary artery was performed.There was no change near sinus compared to preoperative cag.As the blood pressure was low in the 80s, the patient returned to the ward with arterial line placed, but the p-wave returned, and the procedure was completed.The physician's opinion on the cause of the adverse event was that it was procedure related.Based on the intraoperative electrocardiogram (ekg) and cag, ablation was unlikely to be a cause of the issue.Sedation might have affected it.The patient has fully recovered and did not require extended hospitalization.
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Manufacturer Narrative
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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 number lot 31205262l and no internal action related to the complaint was found during the review.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 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.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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