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Model Number FGS-0636 |
Device Problem
Positioning Failure (1158)
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Patient Problems
Apnea (1720); Aspiration/Inhalation (1725); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
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Event Date 06/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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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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According to the reporter, they had a capsule which failed to attach to the patient¿s esophagus and went in the patient¿s lungs.During deployment attempt in the patient, upon pushing the plunger for deployment (prior to plunger rotation), there seemed to be more resistance than normal, and there seemed to be an unusually crunchy/gritty tactile sensation.After device removal, it was noticed that the capsule had come into the mouth, and when they were about to retrieve it, the capsule was aspirated into the lungs, and the patient subsequently desaturated and stopped breathing.The patient's heart rate dropped to the 30's, and systolic blood pressure dropped to the 60's, also the saturation dropped to about 3%, then cardio-pulmonary resuscitation was performed.An emergent bronchoscopy was performed and the capsule was successfully retrieved with forceps.The patient was extubated without needing to go to intensive care unit and just stayed in step-down for observation overnight.Lubrication was used to facilitate the placement of the capsule.
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Search Alerts/Recalls
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