MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number G34281

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

The 510(k) number: k160229.(b)(4).Device evaluation: the echo-hd-22-ebus-o-c device of lot number c1467980 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation, on evaluation of the returned device the device was returned with the original packaging.Device returned with approximately 4.5 cm (specification for needle 77.5 cm +1 mm/-1 mm, ref.) of needle tip returned separately (cut by user).This part of the needle had two visible kinks present.Device not advancing.Part of sheath cut during lab and removed, needle advanced and retracted with no issue.Initial inability to advance due to end of cut sheath adhering to the needle at the 'cut' point.This is also evident from photo of cut needle (sheath stuck to end).Distal end of needle returned with device had two kinks.Adapter not returned with device.The customer complaint is considered to be confirmed as the complaint was verified in laboratory.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However a possible root cause for the occurrence may be due to the device becoming kinked after hitting a hard lesion or when passing through tracheal ring, causing retraction issue.Documents review: prior to distribution, all echo-hd-22-ebus-0-c 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 (b)(4).Ifu review: it may be noted that according to the instructions for use, ifu0109-5, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0109-5).A review of the manufacturing records for echo-hd-22-ebus-0-c of lot number c1467980 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1467980 upon review of complaints this failure mode has not occurred previously with this lot # c1467980.Summary: the customer complaint is considered to be confirmed as the complaint was verified in laboratory.From the information provided: the patient did not experience any adverse effects due to this occurrence the risk associated with this complaint is risk category iii/no risk level.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

Note: needle had to be cut out of endoscope (so it's broken off).As reported to customer relations: "just wanted to let you know dr.(b)(6) had a 22 gauge core needle today that bent 90 degrees after at least 4 passes.We could not pull needle back into sheath.We ended up advancing needle further out scope ,it then straightened enough to safely pull scope with needle out of patient.Scope and patient are fine.The needle would not retract into the sheath even after advancing it so we pulled scope with needle down scope out of patient.I have saved the needle for you i had to cut the needle tip to remove it from scope.All parts are in package at our nursing station.Lot #c1467980.Doctor was about to take her 5th sample from 4r when we noticed the bent needle on the screen.She had been having trouble and hitting tracheal rings.We ended up using a new 22 ga core needle to finish our samples." additional information provided by physician on 21jun2018: "when i advanced the needle further, it did not fully straighten.It still maintained a significant bend in it and at now point could i retract it.By advancing it further it allowed for it to arc a bit more so it wasn't as sharp an angle and more flexible so that as i pulled the whole scope out with the sheath advanced and the needle advanced about 5 cm out of the sheath, i was able to pull it out without harming the patient.None of the needle stayed in the patient but i had to pull the needle out of the patient with it still advanced out of the sheath as i couldn't get it back into the sheath and i didn't want to pull it through the scope which would for sure have damaged the scope.Leaving the needle out didn't damage his airway by scraping it as i was able to be careful taking it out but it had risk to damage him.I was at station 4r.The first few passes were challenging as the tracheal rings were quite tough and required multiple attempts to get into that station.I was often just in the tracheal mucosa and had to refire the needle to get it to go further.On the attempt where the needle bent, the needle was just in the mucosa and i was attempting to refire to get it deeper and he coughed at the same time which is when it bent.The stylet was well placed.".

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY 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: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7702772
• MDR Text Key: 114817506
• Report Number: 3001845648-2018-00321
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)210327(10)C1467980
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1467980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2018
• 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