Model Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problem
Bradycardia (1751)
|
Event Date 03/21/2023 |
Event Type
Injury
|
Event Description
|
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient experienced bradycardia requiring surgical intervention.It was reported that during the case the patient's heart rate dropped down to 30 bpm from 50 bpm and the blood pressure was "so low it was not perfusing".The patient was asymptomatic when they came in but during the ablation was when the drop in blood pressure was noticed.The patient required a pacemaker implant surgery.The patient was stable at the time of the call and went home the same day.This case was not part of a study.The physician¿s opinion on the cause of this adverse event was physiologic issues.They do not have the lot number.The room was cleaned out and as the patient woke up, ¿the heart was noticed¿.
|
|
Manufacturer Narrative
|
The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).
|
|
Manufacturer Narrative
|
The device evaluation was completed on 26-apr-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient experienced bradycardia requiring surgical intervention.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation (mre) was performed for the finished device (b)(4) number, and no internal actions related to the reported complaint condition were identified.Based on the mre, the d4.Expiration date and h4.Device manufacture date have been updated.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The physician¿s opinion on the cause of this adverse event was physiologic issues.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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
|
|