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

Catalog Number ECHO-19

Device Problems Off-Label Use (1494); Material Perforation (2205)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User completed the first seed implantation and attempt the second implantation while found out the stylet penetrated the surface of sheath.User changed another same device to complete the implantation.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.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Pancreas.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.2cm.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.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 needle.Was difficulty experienced while retracting the needle? no.Was the syringe used during the procedure, after the stylet was removed? 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? no.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.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.

Manufacturer Narrative

Device evaluation: the echo-19 device of lot number c1617426 involved in this complaint was returned for evaluation, without its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the devices related to this occurrence underwent a laboratory evaluation on the 12th aug 2020.In summary the following results were observed in the lab evaluation: multiple defects were observed.Sheath and needle damaged.Needle badly bent distally.Needle tip unaccounted for missing, not returned.Needle can advance and retract, however broken parts of sheath move with it.Sheath adjuster functioning fine.Stylet can only be removed approximately 8cm due to bent in needle.Broken parts of sheath removed to reveal breaks in needle, tip missing.Part of needle torn.Following the lab evaluation further additional information was requested to aid with the investigation, "from the additional information provided by customer there is no part of device remain in patient.Customer confirmed no device part remain in patient." 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 c1617426 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 c1617426.The notes section of the instructions for use, se, 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", "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.", ¿step 6.Advance needle into lesion.Step 7.Remove stylet from needle by gently pulling back on plastic hub seated in metal fitting of needle handle.Preserve stylet for use if additional cell collection is desired." there is evidence to suggest that the customer did not follow the instructions for use, as per additional information received, "can you please ask the customer to describe what they mean by seed implantation / target implantation therapy? the patient has pancreatic tail tumour, and user facility used echo-19 to implanted particle(seed) around the tumour as target implantation therapy to attack the tumour only so that other cell or organ can be protected.Can you describe the reason the echo-19 was being used in the patient? implant particle around the tumour as target implantation therapy to attack the tumour only so that other cell or organ can be protected." as per engineering input, "the implantation therapy would have to be considered off label use and could have contributed to the device failure," from additional information provided the stylet was not partially removed prior to advancement of needle, which is considered user error.Root cause review: a definitive root cause could be determined from the available information.From the information provided it is known that the user used the device off-label.As per engineering input,"the implantation therapy would have to be considered off label use and could have contributed to the device failure" multiple defects observed during the laboratory evaluation are related, this could have occurred due to the fact the physician/assistant used the device in a situation not specified for intended use.Additionally, as per additional information provided, there is evidence of user error as the stylet was not partially removed prior to advancement of needle.Multiple defects observed during the laboratory evaluation are related, this could have occurred due to the fact the physician/assistant used the device in a situation not specified for intended use.( reference, health risk assessment hra d00275633 and nc20-036 ).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

This is a follow up report.The lab evaluation of the complaint device was carried out on the 12th aug 2020 and the investigation was completed on 18th aug 2020.Results and conclusions are outlined in section h of this report.User completed the first seed implantation and attempt the second implantation while found out the stylet penetrated the surface of sheath.User changed another same device to complete the implantation.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.2.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Pancreas a.If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.3.Please describe the size of the intended target site.2cm.5.Was the device used in a tortuous position? no.6.Are images of the device or procedure available? no.7.Was it damaged in packaging before removal? no.8.Was it damaged on removal from packaging? no.9.Was force required to remove the device? no.For complaints occurring during use (once in contact with endoscope) also ask: 10.What is the endoscope manufacturer and model number that was used? olympus.11.Was force required on insertion of device into scope? no.12.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? advancement of needle.13.Was difficulty experienced while retracting the needle? no.14.Was the syringe used during the procedure, after the stylet was removed? 15.Was the needle able to be fully retracted before removing from the patient? yes.16.Was gaining access to the targeted site difficult? no.17.Was the endoscope in a flexed or twisted position at any time during the procedure? no.18.Was needle penetration of the targeted site difficult? no.19.Was the stylet partially removed prior to advancement of needle? no.20.How many biopsies/passes were obtained with use of this needle? 1.21.Did any section of the device detach inside the patient? no.22.If kinked below the sheath extender, did they notice the kink before placing the device into the scope? no.23.Was there difficulty or slipping experienced of the sheath extender or lock ring during use? no.24.Was there difficulty in attachment / detachment of the leur to the scope? no.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10372034
• MDR Text Key: 203107091
• Report Number: 3001845648-2020-00474
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)220527(10)C1617426
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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: 05/27/2022
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1617426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/08/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 68