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Catalog Number EUSN-19-T |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Hemostasis (1895)
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Event Date 09/26/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Lee, n.J., et al.(2018).Transcatheter arterial embolization for iatrogenic bleeding after endoscopic ultrasound-guided pancreaticobiliary drainage.Diagnostic and lnterventional lmaging, 99, p.717-724.Https: i / doi.Org/ 1 0.1016/ j.Diii.2018.06.006.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The product line for eusn-19-t was obsoleted in 2015.The instructions for use for ultrasound needles under potential complications states, "those associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest." prior to distribution, all echotip ultrasound needles are subjected to a visual inspection to ensure device integrity.Corrective action: no corrective actions are warranted at this time because device was obsoleted february 2015.The eusn-19-t is a single use disposable device with a 3 year expiration date therefore all devices distributed are beyond their expected life.Quality assurance will continue to monitor for complaint trends.Additional comments regarding this report: based on the information provided that the device was used against the intended use, a cook representative has been requested to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
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Event Description
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The following was reported to cook endoscopy via a clinical literature search: "the purpose of this study was to report the incidence of massive bleeding after endoscopic ultrasound-guided transmural pancreaticobiliary drainage (eus-tpbd) and the clinical outcomes in patients with this condition treated with transcatheter arterial embolization (tae).We performed a 9 year retrospective analysis, from february 2009 to november 2017.All eus-tpbd procedures were performed by expert gastrointestinal endoscopists.Eus-tpbd was carried out using a gf-uct 240 linear-array echoendoscope (olympus medi¬cal systems, tokyo, japan) and was performed by directly puncturing the dilated intrahepatic biliary system, proximal common bile duct or pancreatic duct with a 19-gauge needle (eusn-19-t; cook endoscopy, winston-salem, nc).Then, the tract was dilated using a 4 mm balloon dilatation catheter, and a 4f cannula (glo-tip, gt-1-ut; cook) was advanced over the guidewire.Finally, a plastic stent (double pig tail, cook medical, winston-salem, nc), a fully covered self expandable metal stent (mitech, fc group seoul, korea) or a hybrid stent (bona, standard sci tech, seoul, korea) was then deployed over the guidewire.The incidence of major bleeding complications that needed tae (transcatheter arterial embolization) after eus-tpbd (endoscopic ultrasound-guided transmural pancreaticobiliary drainage) was 1.64%.The median latency time of bleeding after the eus-tpbd was 6 days (range 0-480 days).Patients presented with hematemesis (n=4), hematochezia (n=4), active bleeding during eus-tpbd (n=3), melena (n=1), and unstable vital signs (n=1).Out of 13 bleeding events [12 patients with 1 rebleed], 10 required red blood cells transfusion, with an average of four packs of red blood cells [at least 1 patient, up to 3 patients, received a transfusion due to the puncture].Pseudoaneurysm was observed in four patients.In our present study, the incidence rate of major bleeding complications after eus-tpbd was 1.65% (12/729).Three cases of bleeding were detected immediately after eus-guided puncture during or immediately after eus-tpbd procedure.The bleeding arteries were hepatic and left gastric arteries.We assume that puncture can injure the intervening arteries between the ultrasound and target lumen even under ultrasound guidance." cook's interpretation of this published information is that there are three (3) bleeding events that were due to the puncture and four (4) pseudoaneurysms, totaling seven (7) major bleeding events.It is unclear if the patients who experienced the bleeding events and the patients who experienced pseudoaneurysms overlapped, so they are being captured as a separate quantity out of caution.It was not published in the article if a section of the device remained inside the patient¿s body.Tae (transcatheter arterial embolization) was performed on each patient.At least one patient [up to 3 patients] required rbc transfusion with an average of four packs of red blood cells.Pseudoaneurysms were observed in four patients.It is unknown if the patients experienced any adverse effects due to this occurrence, but no adverse effects were reported in the published article.
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Event Description
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This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the section h10- additional manufacturer narrative-notes for this justification.
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Manufacturer Narrative
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An emdr report was initially sent on 11-dec-2019, based on the information that bleeding occurred after an endoscopic ultrasound-guided transmural pancreaticobiliary drainage (eus-tpbd) and the clinical outcomes in patients with this condition treated with transcatheter arterial embolization (tae).Additional information was received from the author that stated the pseudoaneurysms which occurred after eus-guided puncture were due to a delayed bleeding which was a result of the procedure itself.The pseudoaneurysm was not relevant to the device.Based on the additional information, this incident no longer meets the reporting criteria of an fda mdr report.
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Search Alerts/Recalls
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