Model Number 4FC12 |
Device Problem
Delivered as Unsterile Product (1421)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/17/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during a cryoablation procedure, a ¿white color foreign material was aspirated¿ inside the syringe while the side port was flushed.It was indicated that nothing aspirated after.The procedure was continued and the case was completed with cryo.No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the data files for the date of the reported event were returned and analyzed.The data files can not confirm the reported foreign material issue.The data files confirmed a deflation issue unrelated to the reported issue on applications two and six with the balloon catheter, 2af284 with lot 81581.In conclusion, the reported issue of foreign material can not be confirmed through data analysis.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|