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Catalog Number UNKNOWN |
Device Problems
Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Rpn unknown but possible 510 k #'s include: k142688.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Han - ¿predictors of pain response after endoscopic ultrasound-guided celiac plexus neurolysis for abdominal pain caused by pancreatic malignancy¿ procedure description: patients were hydrated with 500-1000 ml saline solution during the procedure to minimize the risk of hypotension.They were placed in the left lateral decubitus position, and propofol was administered for deep sedation.Vital signs were continuously monitored with an automated non-invasive blood pressure measurement, electrocardiogram, and pulse oximetry.Eus-cpn was performed by using the olympus processor eu-me2 with a linear array endoscopic ultrasonography (gf-uct 260; olympus, tokyo, japan).By tracing the aorta under real-time eus guidance, the base of the celiac artery was identified.Celiac ganglia could be visualized between the celiac artery and the left adrenal gland.Typically for cpn unilateral injection, an echo tip 22-gauge needle (cook medical, inc., winston-salem, nc, united states) primed with normal saline solution was inserted into the operating channel, affixed to the hub, and placed adjacent to the base of the celiac trunk at its origin from the aorta.In cases with bilateral injection, the same procedure was done, but injections were done at both sides of the celiac trunk with clockwise and counter-clockwise rotation (half of the dehydrated 98% absolute alcohol was injected in each side).After confirming no backflow of blood occurred, the celiac plexus injection by dehydrated 98% absolute alcohol was directly applied.A dense hyperechoic cloud was usually seen in the area of injection, and the injection was continued until spilling to the periganglionic space (supplemental material).Whether a bilateral injection was carried out depended on the locations of intervening vessels, the tumor status, and invasion of the celiac plexus or not.Tumors extending to the para-aortic region from the level of the celiac axis to the origin of sma were considered invasive of the celiac plexus.No antibiotics were administered before or post-cpn.All procedures were performed by a single endosonographer.The paper outlines an echo tip 22-gauge needle of unknown rpn was used, possible rpns include: echo-1-22 ¿ intended use as per ifu: this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope echo-hd-22-c ¿ intended use as per ifu: this device is used with an ultrasound endoscope for fine needle biopsy (fnb) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract off label use has occurred as the needle was used eus-cpn (celiac plexus neurolysis) please note that 3 minor adverse events occurred including: hypotension (1.7%) increase of pain (5.2%) and transient loose stools (3.4%) these will be captured within this file as per clinical input all aes would have been because of the off-label use.**this file will capture 58 cases of off-label use with unknown echotip 22g needle**.
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Manufacturer Narrative
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Rpn unknown but possible 510 k #'s include: k142688.Device evaluation: the devices of unknown rpn and lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article "han 2021¿.This file was opened because of 58 cases of off label use with unknown echotip 22g needle.As the rpn and lot number of the complaint is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution echo tip procore devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot numbers are unknown a review of manufacturing records could not be performed.The notes section of the instructions for use, ifu0101-1 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Also, ¿intended use: this device is used to sample targeted submuscosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).A definitive root cause could be attributed to off label use as the device is intended to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.There was no device defect identified within the article.Medical affairs: ¿the device was off-label use.This hypotenion was likely due to the endoscopic procedure or the neurolytic agent injection.¿ ¿the device was off-label use.The transient loose stools was related to neurolytic agent injection.¿ ¿the device was off-label use.This pain was likely due to the endoscopic procedure or the neurolytic agent injection.¿ summary: complaint is confirmed based on customer testimony.According to the initial reporter, 3 minor adverse events occurred, hypotension, increase of pain and transient loose stools.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.
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Manufacturer Narrative
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Rpn unknown but possible 510 k #'s include: k142688.Device evaluation: the devices of unknown rpn and lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article "han 2021¿.Complaint files (b)(4) (3001845648-2021-00322) were opened as a result of this paper.This file was opened because of 58 cases of off label use with unknown echotip 22g needle.As the rpn and lot number of the complaint is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution echo tip procore devices are subjected to a visual inspection and functional checks to ensure device integrity.As the lot numbers are unknown a review of manufacturing records could not be performed.The notes section of the instructions for use, ifu0101-1 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Also, ¿intended use: this device is used to sample targeted submuscosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).A definitive root cause could be attributed to off label use as the device is intended to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.There was no device defect identified within the article.Medical affairs: ¿the device was off-label use.This hypotenion was likely due to the endoscopic procedure or the neurolytic agent injection.¿ ¿the device was off-label use.The transient loose stools was related to neurolytic agent injection.¿ ¿the device was off-label use.This pain was likely due to the endoscopic procedure or the neurolytic agent injection.¿ complaint is confirmed based on customer testimony.According to the initial reporter, 3 minor adverse events occurred, hypotension, increase of pain and transient loose stools.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Supplemental report is being submitted due to a correction to annex e code on the previously submitted mdr report.
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Search Alerts/Recalls
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