Model Number 85020 |
Device Problems
Failure to Deliver Energy (1211); Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/25/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that during a cardiac radiofrequency ablation, a blazer ii catheter was selected for use.During the procedure, ablation the discharge was abnormal, and the adjustment of the tail line could not be solved.The catheter was replaced and the procedure was completed without any patient complications.This catheter is expected to be returned for laboratory analysis.
|
|
Manufacturer Narrative
|
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported that during a cardiac radiofrequency ablation, a blazer ii catheter was selected for use.During the procedure, ablation the discharge was abnormal, and the adjustment of the tail line could not be solved.The catheter was replaced and the procedure was completed without any patient complications.This catheter has been returned for laboratory analysis.
|
|
Manufacturer Narrative
|
The device has been returned for laboratory analysis.Visual inspection did not reveal any abnormalities.Functional testing noted no abnormal resistance while maneuvering the catheter.Electrical and continuity testing were performed, and the device showed all results were within specifications.Laboratory analysis was unable to confirm the reported clinical observations; the device passed all relevant testing.Correction: the field f10 device code has been changed from "defective device a0203" to "failure to deliver energy a090402".
|
|
Search Alerts/Recalls
|