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Model Number FGS-0635 |
Device Problem
Positioning Failure (1158)
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Patient Problem
Aspiration/Inhalation (1725)
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Event Date 07/06/2022 |
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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According to the reporter, they had a capsule which failed to attach to the patient¿s esophagus.After removal of the delivery device, the physician attempted to endoscopically visualize the capsule with the gastroscope.The capsule was unable to be visualized and was not attached to the esophagus.The patient began to gasp and wheeze with a decrease in oxygen saturations into the 80¿s.The patient was immediately intubated.The physician used a bronchoscope to visualize the capsule which was located in the upper bronchial space.The physician was able to pull the capsule above the vocal cords with suction from the bronchoscope.The capsule was then removed with magill forceps and was subsequently extubated.The patient was observed for three hours before discharge without any complaints.Upon examination of the capsule, it appeared the needle did not deploy.No lubrication was used to facilitate the placement of the capsule.
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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.
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Manufacturer Narrative
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Additional information: d4, g1, g3, h3, h4, h6 evaluation summary: medtronic conducted an investigation based upon all information received.The capsule was not returned, but the delivery system was available for evaluation.Visual inspection noted the wire shape was incorrect.It was reported that the capsule failed to attach to the patient's esophagus.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur in a procedure in which the capsule did not attach to the esophageal mucosa.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: carefully advance the delivery device through the mouth (with the capsule facing the patient¿s tongue) to the desired location in the esophagus.Aspiration of the capsule if inadvertently pulled back up into the upper esophagus by the delivery device.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.
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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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Manufacturer Narrative
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In a previous supplemental report, the capa number and reason for the remedial action failed to be included.This report is being submitted in order to provide that information as a correction in field h10.During a regular internal review of complaints, it was identified that some medwatch reports associated with an fca were submitted without a correction/removal number in field h9 of 3500a form.Medtronic have initiated capa pr 576617 to address this gap.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.After removal of the delivery device, the physician attempted to endoscopically visualize the capsule with the gastroscope.The capsule was unable to be visualized and was not attached to the esophagus.The patient began to gasp and wheeze with a decrease in oxygen saturations into the 80¿s.The patient was immediately intubated.The physician used a bronchoscope to visualize the capsule which was located in the upper bronchial space.The physician was able to pull the capsule above the vocal cords with suction from the bronchoscope.The capsule was then removed with magill forceps and was subsequently extubated.The patient was observed for three hours before discharge without any complaints.Upon examination of the capsule, it appeared the needle did not deploy.No lubrication was used to facilitate the placement of the capsule.
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Search Alerts/Recalls
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