Model Number 2AF283 |
Device Problem
Air Leak (1008)
|
Patient Problem
ST Segment Elevation (2059)
|
Event Date 05/12/2017 |
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 cryo ablation procedure, the consultant had bent the mapping catheter wire.The mapping catheter was replaced.Following the replacement of the mapping catheter, st elevation was observed.Additionally, it was indicated that air may have been introduced into the system.The st elevation resolved with no additional issues however the case was aborted.The patient was under general anesthesia.No further patient complications have been reported as a result of this event.
|
|
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 cryo ablation procedure, st elevation was observed.Additionally, it was indicated that air may have been introduced into the system.The st elevation resolved with no additional issues however the case was aborted.The patient was under general anesthesia.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the data files for the date of the event were returned and analyzed.The files showed fifteen injections with balloon catheter, 2af283 lot 73700.No system notices or issues were noted.The air ingress allegation could not be confirmed as no physical product was returned for analysis.Additionally, a known clinical issue was encountered.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
|