MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER - 15 MM; 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 Problems
Hematoma (1884); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 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.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 characteristics is male; the age of the patients was 60 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: immediate and long-term outcomes of cryoballoon catheter ablation in patients with atrial fibrillation and left common pulmonary vein anatomy.¿ journal of interventional cardiac electrophysiology.Doi: https://doi.Org/10.1007/s10840-019-00676-y.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 catheter system: there were four patients who experienced phrenic nerve palsy (pnp); all of which resolved ¿spontaneously¿ during the procedure.There were also patients who had vascular access site complications; including hematomas and pseudoaneurysms; 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/disposition of the cryoablation catheter 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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