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Catalog Number FG540000K |
Device Problem
No Pacing (3268)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and they were unable to perform emergency pacing.During the procedure, could not conduct emergency pacing from the ablation catheter from the pacing cable.Pacing leads were connected to the patient interface unit (piu) primary pacing port.Not ablating at the same time.They replaced to the backup pacing cable immediately.Pacing was possible, so it was determined that the cable was defective.No unintentional pacing was detected.The procedure was completed without patient's consequence.
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Manufacturer Narrative
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The hardware investigation has begun but it has not been 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.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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On 20-dec-2023, additional information was received indicating intended pacing was delivered.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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