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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 01/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred (b)(6).Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/65 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.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: transseptal puncture for left atrial ablation: risk factors for cardiac tamponade and a proposed causative classification system.Journal of cardiovascular electrophysiology.2022;1¿9.Doi: 10.1111/jce.15590 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A journal article was reviewed that contained information regarding cryoballoon ablation and cardiac tamponade.The article reports patients who experienced cardiac tamponade either intra or post ablation procedure.Cardiac tamponade was diagnosed following an attempted transseptal puncture (tsp) with the needle or guidewire, following passage of the sheath(s) beyond the interatrial septum, immediately following withdrawal of sheaths on conclusion of the procedure, during ablation treatment or during manipulation of the ablation catheter, or during recovery from the procedure.Some patients required surgical drainage via median sternotomy or pericardiocentesis, other intervention included a stepwise combination of protamine, concentrated clotting factors, vitamin k, fresh frozen plasma or cryoprecipitate was administered or acquired coagulopathy or blood transfusion.The status/disposition of the catheters, needles, and sheaths is unknown.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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