Catalog Number D134805 |
Device Problems
Insufficient Cooling (1130); Device Emits Odor (1425); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the issues occurred of the catheter no longer flushing after it had been used in the patient and the melted plastic smell.During the procedure, the catheter was flushed and put into the body.They received the error message "temperature too high, high electrode temperature; the temperature exceeded cut-off" on the ngen system.There was a "melted plastic smell" and the catheter was no longer flushing.To troubleshoot they checked for char and verified there was none, and the smartablate tubing was checked without resolution.They replaced the cable and catheter.The issue resolved and the procedure was continued.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The error message ¿temperature too high, high electrode temperature; the temperature exceeded cut-off" was assessed as non mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The catheter no longer flushing after it had been used on the patient was assessed as mdr reportable.The ¿melted plastic smell¿ issue was also assessed as mdr reportable.
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Search Alerts/Recalls
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