MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 990063-015 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Blood Loss (2597)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.The baseline gender/age characteristics is male/59 years old.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.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: ¿cryoballoon vs.Radiofrequency ablation for atrial fibrillation: a study of outcome and safety based on the esc-ehra atrial fibrillation ablation long-term registry and the swedish catheter ablation registry.¿ europace (2018) 00, 1¿9.Doi:10.1093/europace/euy239.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The literature publication reports the following patient complications while using a cryoablation balloon/mapping catheter: there were eight (8) patients who had cardiac perforation/tamponade.There were three (3) patients with air ingress embolisms, one (1) patient with a thrombosis-embolism, four (4) patients with stroke/tia, fifteen (15) patients with phrenic nerve palsy (pnp), one (1) patient with bleeding, one (1) patient with pleural effusion, and nine (9) patients with ¿unknown-other¿ complications.Of note, multiple patients and multiple methods were noted in the article; however, a one to one correlation could not be made with unique product lot numbers/methods.There were no details provided regarding any intervention taken and/or resolution noted.The status/location of the cryoballoon/mapping 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.
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