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

Catalog Number ECHO-1-22

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2020

Event Type  malfunction  

Event Description

Wang et al 2020 - wet- versus dry-suction techniques for endoscopic ultrasoundguided fine-needle aspiration of solid lesions: a multicenter randomized controlled trial.The aim of this study was to compare the wet-suction and dry-suction techniques for sampling solid lesions in the pancreas, mediastinum,and abdomen.The study was conducted at four tertiary care centers in china, including tongji hospital, union hospital, renmin hospital of wuhan university, and the central hospital of wuhan.The 296 consecutive patients underwent eus-fna with 22g needles and were randomized in a ratio of 1:1 into two separate groups that received the dry-suction and wet-suction techniques in a different order.Four needle passes were taken from each lesion using a 22g needle (echotip ultra, cook medical, winston salem, north carolina, usa) with each of the two suction methods described below.For dry suction, after puncturing the lesion, the endoscopist removed the stylet and attached a 5-ml pre-vacuum syringe for aspiration.For wet suction (fig.1 s, see online-only supplementary material), the stylet was removed and the needle was pre-flushed with 1 ¿ 2ml of saline using a 10-ml syringe, the endoscopist then punctured the lesion and replaced the 10-ml syringe with a 5-ml pre-vacuum syringe.Each pass consisted of 20 back-and-forth movements of the needle within the lesion, using the fanning technique whenever possible.Afterwards, the needle was withdrawn from the lesion.There were no major adverse events reported in this study.The rate of minor adverse events relating to the eus-fna procedure was 0.7 %.This file was opened to capture one patient who developed an asymptomatic rise in amylase level potentially using the wet suction technique.Rise in amylase level does not meet criteria of a serious injury but user error has the potential for serious injury.Two separate groups received the dry-suction and wet-suction techniques in a different order.It can be noted that the use of the wet-suction technique was user error.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of the investigation.

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 journal article "wang - wet versus dry suction techniques for endoscopic ultrasound guided fine needle.Pdf" this complaint (b)(4) (report reference number - 3001845648-2021-00337) was opened to capture the asymptomatic rise in amylase level (user error).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 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 may not have followed the instructions for use due to the fact they used the wet-suction technique in conjunction with the dry-suction technique but as it is unclear what technique was used in this case.A separate file will investigate the dry-suction technique & (b)(4) (report reference number - 3001845648-2021-00337) will investigate the wet technique scenario.(ifu0101).A definitive root cause could be determined from the available information.The root cause can be attributed off-label use because the physician using the wet suction technique which is not permitted ad per the instructions for use.As per clinical "the wet-suction technique was off label use as per the supplementary data" complaint is confirmed based on customer testimony.According to the initial reporter, the patient experienced an asymptomatic rise in amylase level.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Pma/510(k) # k210476.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.Reference "wang - wet versus dry suction techniques for endoscopic ultrasound guided fine needle.Pdf" this complaint pr (b)(4) (emdr ref.(b)(4)) was opened to capture the asymptomatic rise in amylase level (user error).The increase in amylase level observed in this instance was not caused by the user error of the device and is captured in pr (b)(4) - wang et al 2020 - asymptomatic rise in amylase level.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 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 submucosal 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 as they used the wet-suction technique.Image review: n/a.Root cause review: a definitive root cause could be attributed to use error as the physician used the wet suction technique this technique is not permitted as per the instructions for use in the instructions for use the dry suction technique is detailed "turn stopcock to ¿open¿ position aligned with syringe, allowing negative pressure in syringe to aspirate cells.Gently move handle in small increments back and forth within biopsy site.Note: do not remove needle from biopsy site during cell collection." 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 mdr report is being submitted due to cancellation of file.On completion of investigation on 17 may 2023 this event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Use error situation: physician/assistant does not read/ follow instructions.Overall risk assessed as category iii (no risk).No reporting malfunction precedence exists for this complaint event for this product family.No risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.

• 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: 11730846
• MDR Text Key: 280549957
• Report Number: 3001845648-2021-00337
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-1-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/29/2021
• 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: 58 YR
• Patient Sex: Male