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
Vascular System (Circulation), Impaired (2572)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of medical devices: arctic front advance cardiac cryoablation catheter 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/56 years old.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot 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: ¿left atrial geometry and outcome of atrial fibrillation ablation: results from the multicentre lago-af study.¿ european heart journal - cardiovascular imaging (2018) 19, 1002¿1009.Doi:10.1093/ehjci/jey060.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 reported the following patient complications during the use of a cryoballoon ablation system: there were three (3) patients who developed cardiac tamponade; four (4) patients with vascular access complications, three (3) patients with pericarditis; all with unknown treatment/resolution.There were also the following complications: one each for transient ischaemic attack, phrenic nerve palsy, acute pulmonary oedema, and haemoptysis, all with unknown treatment/resolution.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The status/location of the cryoablation system 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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Search Alerts/Recalls
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