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

Catalog Number ECHO-HD-22-EBUS-P

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k160229 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User detected the sheath kink which prevent needle advacement.User then changed to another same device to complete the procedure.Additional information received (b)(6) 2022: user error stylet partially removed (pr 368910), unable to retract needle, (pr 364717) "a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." are images of the device or procedure available? yes, attached in file.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? handle and sheath conjunction area.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? no.If the device is a procore needle, is the device damage located at the notch / core trap? no.Procore.If no, please specify where the damage is located: please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Mediastinal lymph nodes if the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.2r,2l,4r,ao,ar,11ri,11s.Please describe the size of the intended target site.Unknown.If not with the device in question, how was the procedure performed and/or finished? with another same device to complete the procedure.Was the device used in a tortuous position? no.Are images of the device or procedure available? no.Was it damaged in packaging before removal? no.Was it damaged on removal from packaging? no.Was force required to remove the device? no.For complaints occurring during use (once in contact with endoscope) also ask: what is the endoscope manufacturer and model number that was used? pentax was force required on insertion of device into scope? no.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? advancement of the sheath.Was difficulty experienced while retracting the needle? yes.Was the syringe used during the procedure, after the stylet was removed? no.Was the needle able to be fully retracted before removing from the patient? no.Was gaining access to the targeted site difficult? yes.Was the endoscope in a flexed or twisted position at any time during the procedure? no.Was needle penetration of the targeted site difficult? yes.Was the stylet partially removed prior to advancement of needle? slightly removed how many biopsies/passes were obtained with use of this needle? 1.Did any section of the device detach inside the patient? no.If kinked below the sheath extender, did they notice the kink before placing the device into the scope? yes was there difficulty or slipping experienced of the sheath extender or lock ring during use? no.Was there difficulty in attachment / detachment of the leur to the scope? no.If the device is procore and it is kinked distally, is the kink at the notch / core trap? no procore.Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no.Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? yes, detaching the device to the accessory channel port on the scope.When the needle tip was advanced into the target site was the distal scope position adjusted so as to strain or flex the needle? yes.If an ebus procedure did the needle tip hit the cartilage rings of the trachea? no, ebus.

Manufacturer Narrative

Pma/510(k) # k210476.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted based on the lab evaluation conducted on 04 august 2022.Visual inspection: distal end of needle examined and no issue observed.Needle kink observed below sheath extender.Functional inspection: sheath extender unable to advance past kink below sheath extender but able to retract without difficulty.Needle able to advance and retract with slight difficulty.

Manufacturer Narrative

Pma/510(k) # k210476 device evaluation 1 unit of lot c1892259 of echo-hd-22-ebus-p was returned opened in its original packaging.It should be noted that this file is related to another complaint file.For details of the other investigation please refer to (b)(4) (report reference number (b)(4)).Clarification was requested as follows; ¿i am looking for clarification regarding the answer to q.26 of the additional questions and the complaint description the answer ¿yes¿ to q.26 would indicate that the user noticed the failure of kink below the sheath extender but still placed it in the scope to use it.However, the complaint description would seem to indicate that when the user noticed the failure they stopped using it and changed to another device to complete the procedure.Can you please clarify which of the above is correct?¿ reply was received as follows; ¿the answer of question 26 should be no¿ lab evaluation the device involved in the complaint was evaluated in the laboratory on 04 august 2022.A proximal kink below the sheath extender was observed on the device returned.The needle was able to advance and retract with slight difficulty.Clarification was requested as follows; ¿can you please confirm if the kink below the sheath extender could be linked to the user error issue of stylet partially removed prior to advancement of needle¿ reply was received as follows; ¿i don¿t believe they¿re linked, in my opinion the sheath/needle damage occurs when the handle/device is allowed to suspend from the scope¿ document review including ifu review prior to distribution, all echo-hd-22-ebus-p 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.A review of the manufacturing records for echo-hd-22-ebus-p of lot number c1892259 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1892259.The notes section of the instructions for use, ifu0060-5 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¿ and "ensure the stylet is fully inserted when advancing the needle into the target site¿ there is evidence to suggest that the customer did not follow the instructions for use in relation to the use of the stylet (ifu0060-5).This will be investigated under (b)(4).Image review n/a root cause review a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to observed needle kinking below the sheath extender which led to the needle advancement difficulties reported in the complaint description and the needle retraction issue detailed in q.17 of the additional questions.This could also have led to the difficulty detaching the device from the scope as per q.31 of the additional questions.This kink may have occurred due to the difficulty accessing the target site as per the additional information or may have happened when the handle/device is allowed to suspend from the scope has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction summary complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient 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 report is being submitted due to the completion of the investigation.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD 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: 15155665
• MDR Text Key: 304979435
• Report Number: 3001845648-2022-00492
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002534084
• UDI-Public: (01)10827002534084(17)241201(10)C1892259
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-P
• Device Lot Number: C1892259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/26/2022
• Event Location: Hospital
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 65 KG