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Model Number DSN-22-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Respiratory Distress (2045)
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Event Date 12/23/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Title: randomized non-inferiority trial comparing diagnostic yield of cytopathologist-guided versus seven passes for endoscopic ultr asound-guided fine-needle aspiration of pancreatic masses.Source: linda s.Lee, division of gastroenterology, hepatology and endoscopy, brigham and women¿s hospital, 75 francis st., boston, ma 02115, usa.Email: lslee@partners.Org received 27 october 2015; accepted 16 december 2015.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, this was study regarding a comparison between 2 methods of using the aspiration needle.There were findings of complications on both methods.Post study revealed that there were 5 complications in the cytopathologist -guided arm which included three acute pancreatitis wherein one patient had undergone an endoscopic retrograde cholangio-pancreatography at the same time obtaining adequate aspirate of solid mass (pancreatic) using eus.There was one patient that fell during the recovery period, but without associated injuries.The last patient had a broken needle requiring removal of the echoendoscope.Based from the seven-passes there were three complications which included to one patient experiencing an intraprocedure bradycardia that was responded with atropine.Another patient experienced a respiratory distress leading to the procedure being aborted.The last patient developed abdominal pain and fever (normal laboratory studies and abdominal computed tomography) that eventually resolved spontaneously.
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Manufacturer Narrative
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This event has been reassessed and found to be a non-mdr reportable complaint.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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Search Alerts/Recalls
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