MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
|
Back to Search Results |
|
Model Number 990063-020 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/21/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Continuation of d10: product id: 2035u, product type: electrical umbilical cable.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.
|
|
Event Description
|
It was reported that during a cryo ablation procedure, a system notice was received during catheter set-up indicating that the system did not recognize the catheter.The electrical umbilical cable was replaced, but the issue persisted, so the electrical umbilical cable was replaced again which resolved the issue.Additionally, when the mapping catheter was taken out of the package, the tip of the ring appeared to be bent.The mapping catheter was replaced which resolved the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|