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

Catalog Number ECHO-19

Device Problem Off-Label Use (1494)

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

Event Date 04/09/2021

Event Type  malfunction  

Event Description

User used needle to puncture the fundus of stomach to desired position while found out the embolization coil cannot be released.User retracted the device and changed to another same device to complete the procedure.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.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)? patient end.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.) liver.If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.Please describe the size of the intended target site.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? olympus uct260.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? while releasing coil.Was difficulty experienced while retracting the needle? no.Was the syringe used during the procedure, after the stylet was removed? yes.Was the needle able to be fully retracted before removing from the patient? yes.Was gaining access to the targeted site difficult? no.Was the endoscope in a flexed or twisted position at any time during the procedure? no.Was needle penetration of the targeted site difficult? no.Was the stylet partially removed prior to advancement of needle? yes.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? no.As 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?.

Manufacturer Narrative

Device evaluation: 1 unit of lot c1785524 of echo-19 was returned opened in its original packaging.Lab evaluation: the device involved in these complaints were evaluated in the laboratory on 19 may 2021.Stylet partially removed on return.Sheath extender able to advance and retract without issue.Needle able to advance and retract without issue.Distal end of needle observed to be kinked.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 c1785524 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 c1785524.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 evidence to suggest that the customer did not follow the instructions for use as "the physician used echotip needle as an access needle to deploy the embolization coil, which would be considered off-label use despite the location e.G., liver or stomach." (ifu0101-1).Image review: n/a.Root cause review: a definitive root cause for the customer complaint could be attributed to off label use as "the physician used echotip needle as an access needle to deploy the embolization coil, which would be considered off-label use despite the location e.G., liver or stomach." 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.

• 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: 13531760
• MDR Text Key: 288469665
• Report Number: 3001845648-2022-00082
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)231211(10)C1785524
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2023
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1785524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2021
• Event Location: Hospital
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2020
• 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: 55 YR
• Patient Sex: Male