Model Number 4FC12 |
Device Problem
Air Leak (1008)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/03/2017 |
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, when the sheath was flushed continuously, an ¿occlusion alarm¿ (alarm from the infusion pump) was triggered.A sheath port check confirmed air ingress.An attempt was made to perform air aspiration but a syringe was unable to be pulled out.The balloon catheter was thus extracted once and air aspiration was performed.Then, the balloon catheter was inserted again and no air was confirmed in the product.Ablation was started but the occlusion alarm was triggered multiple times.The procedure continued and 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 event were returned and analyzed.The files show at least ten applications with balloon catheter, 2af284 lot 17118, and eight applications with electrophysiology (ep) catheter, 239f3 lot 15994.No system notices or issues were noted.Further results pending the returned product analysis.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Event summary: upon visual inspection of flexcath sheath 4fc12 / 68329-053, results showed the device were intact with no apparent issues.Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath.The unable to aspirate report could not be reproduced.Dissection showed the hemostatic valve was leaking; valve was torn.The sheath failed the test due to leaking homeostatic valve.The sheath 4fc12 is flushed/aspirated upon inserting arctic front advance catheter.The od of the balloon proximal bonding was in specification (less than 0.155 inches).Insertion and retraction tests were performed without friction.In conclusion, the reported issue air ingress during aspiration has been confirmed through testing but not through the data analysis.The reported issue (unable to aspirate) has been not confirmed through the testing and data analysis.The sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|