MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 990063-020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Cardiac Perforation (2513)
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Event Date 01/30/2024 |
Event Type
Injury
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Event Description
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It was reported that during a cryo ablation procedure, after the transeptal puncture, when the upper pulmonary vein (pv) was frozen, the mapping catheter penetrated the pericardium.Imaging of the pericardium showed that a cardiac tamponade was present in the peri cardium.The patient became hypotensive.The patient's bleeding could not be stopped after emergency treatment, therefore a thoracotomy was performed.The case was aborted.The patient was not under general anesthesia.The patient's hospitalization was extended. 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: product id (b)(4); product type: balloon catheter product id (b)(4) ; product type: 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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Manufacturer Narrative
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Product event summary: the 990063-020 mapping catheter with lot number 227669014 was returned and analyzed.Visual inspection of the mapping catheter showed it was intact with no apparent issues.No kinks were observed along with the shaft, pebax, or tip/loop section of the mapping catheter.The functional test was performed using a multimeter.The mapping catheter was connected to the test cable and the continuity and impedance measurement between the electrodes and the other side of the cable showed the electrode's continuity and impedance to the cable were normal.In conclusion, the clinical issues of cardiac tamponade, perforation, hypotension, bleeding occurred during the procedure with no indication that the adverse event was related to the performance or a malfunction of the product and the mapping catheter passed the returned product inspection.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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