MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
|
Back to Search Results |
|
Model Number 2ACH20 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/25/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that during a cryo ablation procedure, after opening the mapping catheter packaging, the mapping catheter tail end was found to be kinked.The mapping catheter was replaced to resolve the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Manufacturer Narrative
|
Product event summary: the 2ach20 mapping catheter with lot number 8709953 was returned and analyzed.Visual inspection was performed and the loop segment area showed the loop was intact with no apparent issues.No damage was observed along with the tip/loop section of the mapping catheter.The pebax tubing area was intact with no apparent issues.No damage was observed along with the tubing section of the mapping catheter.The electrodes were intact with no apparent issues.All electrodes existed on the loop section and no cosmetic issue or anomalies were identified.The shaft was broken from the from lemo connector.The introducer was intact with no apparent issues.No damage or any other issue was observed along with the introducer.The lemo connector was intact with no apparent issues.No damage or any other issue was observed along with the lemo connector.In conclusion, the reported kink issue was confirmed through analysis and the mapping catheter failed the returned product inspection due to a broken shaft.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|
|
|