MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-1-22

Device Problem Off-Label Use (1494)

Patient Problems Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Rosa et al 2021- eus-guided fine needle tattooing (eus-fnt) for preoperative localization of small pancreatic neuroendocrine tumors (p-nets) the aim of this paper is to evaluate the safety and efficacy of preoperative endoscopic ultrasound guided fine needle tattooing (eus-fnt) to facilitate intraoperativedetection of pnets.Retrospective revision of prospectively maintained database of consecutive patients with pnets who, between january 2015 to april 2019, have undergone eus-fnt and subsequent surgical resection at the fondazione policlinico a.Gemelli irccs, rome, italy.Eus-fnt was done using a 22-gauge fna needle (echotip ultra, cook endoscopy, winston-salem, n.C.) previously filled with a solution of highly purified carbon particles (spot®, gi supply, comp hill, pa, us).The needle was advanced directly into the center of the lesion or immediately adjacent to the lesion towards the pancreatic head and tattooing was then performed by gentle intralesional or intrapancreatic injection of 1¿2 ml of the spot® solution, until a hyperechoic spot appeared in the eus field of view in the proximity of the needle tip.The volume of spot® ink that was injected varied between 1¿2 ml, depending on the size of the lesion and the corresponding pancreatic segment.After injection, the needle was left in place for 30 s and then withdrawn, to decrease the risk of ink spilling outside of the tumor.The procedure was carried out using the conventional curvilinear eus.Tattooing was performed by intralesional injection of 1¿2 ml of spot® ink (spot®, gi supply, comp hill, pa, us) using a standard 22 gauge eus fna needle.A total of 16 patients underwent eus-fnt during the study period.There were 5 males and 11 females,with a mean age of 53 years (range 21¿73).Twelve were functional insulinomas, while the other 4 were nfpnets, with a ki-67 between 4 and 5%.Fifteen days from the eus-fnt procedure, a small hematoma and retraction of the pancreatic capsule were intraoperatively detected.The hematoma, however, did not interfere with the planned surgical resection.This complaint opened to capture the off-label use of the echo-1-22 device.

Manufacturer Narrative

Device evaluation the echo-1-22 devices of unknown 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 attached journal article.This complaint was opened to capture the off -label use of echo-1-22 device lab evaluation n/a document review including ifu review prior to distribution, all echo-1-22 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is 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).Image review n/a root cause review a definitive root cause could be attributed to off label use as tattooing was performed by intralesional injection of 1¿2 ml of spot® ink (spot®, gi supply, comp hill, pa, us) using a standard 22 gauge eus fna needle.Summary complaint is confirmed based on customer testimony.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 21-jan-2022.

Manufacturer Narrative

The echo-1-22 devices of unknown 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 "rosa - 2021_eus-guided fine needle tattooing".This complaint was opened to capture the off -label use of echo-1-22 device.Prior to distribution, all echo-1-22 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is 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 tattooing was performed by intralesional injection of 1¿2 ml of spot® ink (spot®, gi supply, comp hill, pa, us) using a standard 22 gauge eus fna needle.Complaint is confirmed based on customer testimony.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This correction supplemental follow-up is being submitted because the annex e and f codes were amended on 15-mar-2022, follow up mdr scheduled to include this update.

Event Description

This correction supplemental follow-up report is being submitted due to the correction of the section f 10.Health effect - impact code (annex f) f26 ( - no health consequences or impact) corrected to f11( - minor injury/ illness / impairment).

Manufacturer Narrative

The echo-1-22 devices of unknown 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 "rosa - 2021_eus-guided fine needle tattooing." this complaint was opened to capture the off -label use of echo-1-22 device.Prior to distribution, all echo-1-22 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is 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).A definitive root cause could be attributed to off label use as tattooing was performed by intralesional injection of 1¿2 ml of spot® ink (spot®, gi supply, comp hill, pa, us) using a standard 22 gauge eus fna needle.Complaint is confirmed based on customer testimony.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 11743593
• MDR Text Key: 280547082
• Report Number: 3001845648-2021-00354
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-1-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/21/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female