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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Fistula (1862); Hematoma (1884); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605)
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Event Date 12/01/2018 |
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.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/weight characteristics is male/64 years old/23 kgs.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: prevalence and characteristics of venous thrombosis after catheter ablation of atrial fibrillation in patients receiving periprocedural direct oral anticoagulants.J atr fibrillation.2018 dec 31;11(4):2090.Doi: 10.4022/jafib.2090.Ecollection 2018 dec.Doi:// 10.4022/jafib.2090.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 patients with deep vein thromboses (dvts); leg pain and swelling.There were also patients who experienced vascular access complications; including femoral arterio-venous fistulas, groin hematomas, and pseudoaneurysms.There was medical and/or surgical intervention taken some patients.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 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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was obtained through follow up with the company representative who provided additional information; which included: the product was discarded by the customer, and that the "large catheter may have caused the dvt, but it is not definite.".
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Search Alerts/Recalls
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