MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
|
Back to Search Results |
|
Model Number 2ACH20 |
Device Problems
Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/26/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product event summary: the mapping catheter 2ach20 with lot 11138639, was returned and analyzed.Visual inspection showed that the pebax tube was detached and the loop was damaged as it was stuck inside the luer.Additional imaging showed that four electrodes were stuck inside the luer of the catheter.In conclusion, the mapping catheter failed inspection due to loop damage and detachment.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
After a completed case, the balloon catheter and mapping catheter subsequently tested out of specification per the manufacturer's investigation.
|
|
Search Alerts/Recalls
|
|
|