MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
|
Back to Search Results |
|
Model Number 990063-015 |
Device Problem
Kinked (1339)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/05/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product event summary: the device was returned and analyzed.Visual inspection of mapping catheter showed that the loop was kinked in several places.The catheter was connected to the diagnostic computer and channel pairs 1-2 and 2-3 displayed noises.A dissection showed that the catheter electrodes-wire of pin # 2 had been detached from the weld.Also, blood and flattened ecg rings were discovered inside the pebax shaft that suggested the failure occurred during use.In conclusion, the reported issue of no signal was confirmed through testing.The catheter failed the return product inspection due to a detached electrode-wire and kink.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 electrodes on the mapping catheter were not functioning properly.The case was completed with cryo.The device was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|