MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER - 15 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
|
Back to Search Results |
|
Model Number 990063-015 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Vascular System (Circulation), Impaired (2572)
|
Event Date 01/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The overall baseline gender/age characteristics is male/58 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: results of the randomized 123 study.¿ pace - pacing and clinical electrophysiology.2019; doi://10.1111/pace.13626.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The literature publication reported the following patient complication during the use of a mapping catheter: there were three (3) patients who had vascular complications; all of which were treated ¿conservatively.¿ of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The status/disposition of the catheter is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|