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

Catalog Number ECHO-19

Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The needle punctured the sheath.Did any section of the device remain inside the patient body? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedure(s)? no.Were there any adverse effects on the patient due to this occurrence? no.Did the product cause or contribute to the adverse effect(s)? no.1.1 for complaints, ask: 1.1.1 if the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? unknown 1.1.2 please describe the location in the body for the intended target site (pancreas, stomach, etc).Pancreas a.If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.1.1.3 please describe the size of the intended target site.Unknown 1.1.4 if not with the device in question, how was the procedure performed and/or finished? they finished procedure after using the another echo-19 product.1.1.5 was the device used in a tortuous position? yes, it was.1.1.6 are images of the device or procedure available? those images are not available.1.1.7 was it damaged in packaging before removal? no, it wasn't.1.1.8 was it damaged on removal from packaging? no, it wasn't.1.1.9 was force required to remove the device? for complaints occurring during use (once in contact with endoscope) also ask: 1.1.10 what is the endoscope manufacturer and model number that was used? olympus gf-uct260 1.1.11 was the scope recently serviced / repaired? unknown 1.1.12 was force required on insertion of device into scope? no, it wasn't.1.1.13.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? the needle did not puncture the lesion.1.1.14.What is the endoscope manufacturer and model number that was used with this device? olympus gf-uct260 1.1.15.Was difficulty experienced while retracting the needle? unknown 1.1.16.Was the needle able to be fully retracted before removing from the patient? unknown 1.1.17.Was gaining access to the targeted site difficult? yes, it was.1.1.18.Was the endoscope in a flexed or twisted position at any time during the procedure? yes, it was.1.1.19.Was needle penetration of the targeted site difficult? yes, it was.1.1.20.Was the stylet fully in place inside the needle when advancing into the targeted site? no, it wasn't 1.1.21.Was the stylet partially removed prior to advancement of needle? yes, it was.1.1.22.How many biopsies/passes were obtained with use of this needle? unknown 1.1.23.Did any section of the device detach inside the patient? no 1.1.24.If kinked below the sheath extender, did they notice the kink before placing the device into the scope? unknown 1.1.25.Was there difficulty or slipping experienced of the sheath extender or lock ring during use? unknown 1.1.26.Was there difficulty in attachment / detachment of the leur to the scope? no, it wasn't 1.1.27.If the device is procore and it is kinked distally, is the kink at the notch / core trap? 1.2 for complaints specific to the echotip ultra fiducial needle, rpn echo-22-f 1.3 if reported difficulty was experienced after placement procedure 1.3.1 what system was used to view fiducials for administration of therapy?.

Manufacturer Narrative

Device evaluation: complaint device was not returned therefore a document based review will be performed.Lab evaluation: n/a.Document review including ifu review: prior to distribution, all echo-19 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-19 of lot number c1829758 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 c1829758.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".There is no 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 not be determined from the available information.A possible root cause could be attributed to the device being in a torturous position, this could potentially have led to the needle kinking distally and becoming stuck on the sheath at some point during the procedure, leading to the needle piercing the sheath.Another possible root cause could be that it may have become kinked on attachment or detachment of the scope.Summary: complaint is confirmed based on the customer's testimony.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 follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the (b)(6) 2022.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12588153
• MDR Text Key: 283820455
• Report Number: 3001845648-2021-00713
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)240517(10)C1829758
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2024
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1829758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/08/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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