Catalog Number D134702 |
Device Problems
Insufficient Cooling (1130); Obstruction of Flow (2423); Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/27/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
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).
|
|
Event Description
|
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter which was not delivered fluid properly.During pvc ablation on left ventricle, radiofrequency was not able to be delivered because there was a rise in temperature when starting the button of ngen.The catheter cable was changed and the problem persist.Doctor pulled out the ablation catheter from the patient and he realized that catheter shaft was twisted and because of that, fluid was not delivered properly and ablation was not allowed by the ngen generador.A new catheter was used and the problem was solved.The case was finished without problems for the patient.
|
|
Manufacturer Narrative
|
On 24-apr-2024, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
|
|
Search Alerts/Recalls
|
|