Catalog Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problem
Heart Block (4444)
|
Event Date 03/08/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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).
|
|
Event Description
|
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced complete heart block.During an svt case, it was noticed that the patient went into complete heart block.The medical team was ablating the slow pathway, and after coming off ablation, it was noticed that the patient went in heart block; noticed on the recording system.Prior to this, there were no abnormal readings, and no abnormal catheter movement.The patient was in heart block for a few minutes, and then normal sinus rhythm had restored.The patient was in stable condition on a friday, but the patient went back into heart block over the weekend.There is no confirmation of any medical intervention provided at this time.
|
|
Manufacturer Narrative
|
On 26-apr-2024, bwi received additional information regarding the event.The physician's opinion on the cause of this adverse event is procedure.The intervention was medication to help the patient's condition.The patient was monitored until returning to normal sinus rhythm.The patient improved and did not require extended hospitalization.The patient's age and sex have also been provided and has been updated in section a of this form.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
|
|
Search Alerts/Recalls
|
|