MEDTRONIC CRYOCATH LP FREEZOR MAX CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number 239F5 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Cough (4457)
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Event Date 12/27/2022 |
Event Type
Injury
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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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It was reported that during a cryo ablation procedure, the patient's blood pressure decreased. echocardiogram showed cardiac tamponade.Tracheal intubation and drainage were performed which helped stabilize the blood pressure.However, the blood pressure decreased again during hemostasis.Cardiac massage and drainage were resumed which helped remove the tamponade.The patient was transported to the intensive care unit (icu) and the case was completed with cryo.The physician stated that this could be because that the "rv" catheter was inserted too deep.The patient was coughing during the case so the catheter was "scratched".Hemorrhaging was also observed. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d10: 4fc12 sheath.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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2023-01-25: it was also reported that the patient underwent pulmonary vein isolation (pvi) followed by cavotricuspid isthmus isolation (cti).The patient was coughing during the pvi portion of the procedure, but not during the cti portion of the procedure.It was also reported that the cardiac massage was performed outside of the patients chest, meaning chest compressions were performed.It was also reported that the left inferior pulmonary vein (lipv) had been perforated prior to the hypotension, hemorrhage, and tamponade.The perforation was not noticed while the patient was in the operating room.No further patient complications have been reported as a result of this event.
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