MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
|
Back to Search Results |
|
Model Number 2ACH20 |
Device Problems
Entrapment of Device (1212); Material Twisted/Bent (2981)
|
Patient Problem
Physical Entrapment (2327)
|
Event Date 01/27/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
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 mapping catheter became stuck in the pulmonary vein (pv).The mapping catheter was able to be removed from the pv, and it was noted there was a bend at the base of the mapping catheter.The mapping catheter was replaced, resolving the issue.The case was completed with cryo.
|
|
Manufacturer Narrative
|
Correction: b5 product event summary: the 2ach20 mapping catheter with lot 5998184 was returned and analyzed.Visual inspection showed the loop section was kinked.A clinical issue(entrapment) was encountered during the procedure.In conclusion, the reported entrapment and shaft kink were not confirmed.There is no indication of relation of adverse event to the performance of the product.The mapping catheter failed the returned product inspection due to a loop kink.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
|
No further patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|