MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-19-C

Device Problems Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k142688.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

During the eus procedure, the needle was bent at the first attempt when the lesion was punctured in the fundus.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))? distal end please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Stomach 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? new needle if used.Was the device used in a tortuous position? yes.Are images of the device or procedure available? no.Was the device damaged in packaging before removal? no.Was the device 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? olimpus gf-utc 180.Was the scope recently serviced / repaired? no.Was resistance felt while inserting the device through the scope? no.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? on advancement of the needle.Was the syringe used during the procedure, after the stylet was removed? no.Was difficulty experienced while retracting the needle? yes.Was it possible to fully retract before removing the needle from the patient? no.Was gaining access to the target site difficult? no.Was the endoscope in a flexed or twisted position at any time during the procedure? yes.Was puncture of the target site difficult? no.Was the stylet partially removed when advancing into the target site? yes.How many samples were obtained with this needle? yes.Did any section of the device detach inside the patient? no.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? no.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 of the leur lock to the scope? no.If the device is a procore, is the kink located distally at the notch / core trap? yes.Is the patient known to be covid-19 positive? i don¿t no the item will be shipped today.

Manufacturer Narrative

Pma/510(k) #: k142688.G code: g04126 - stylet.1 unit of lot c1406273 of echo-hd-19-c was returned opened in its original packaging.Clarification was requested from cirl engineering as follows; ¿looking for your input.The actual complaint relates to an issue where the needle was bent at the first attempt when the lesion was punctured.According to information provided, this device was used during procedure on the (b)(6) 2020.Upon review of the sample label attached to the work order ((b)(4)), the expiry date of the device is confirmed to be 3rd oct 2020.This confirms that the complaint device was used after its expiry date.Would you be able to determine/assess the impact on the functionality of using this device outside of its expiry date? is it possible that it would have contributed to the needle bent failure?¿ reply was received as follows; ¿the out of date situation would not have impacted the performance of the needle¿ as a result of the above an additional file was opened for ¿use of an expired device' the device related to this occurrence underwent a laboratory evaluation on 17 dec 2020 and a re-evaluation on the 22 dec 2020 and the 12 feb 2021.The following was noted after the first and second lab evaluations on 17 dec and 22 dec 2020; unable to advance or retract needle from device.A proximal kink below the sheath extender was observed.Clarification was requested after the second lab evaluation as follows; ¿first question: it was not possible to retract the needle handle to position 0 and it was also not possible to remove the needle from the device to examine for kinks/breaks (see photos below).There seems like a strong resistance against the needle handle when trying to retract it fully to position 0.It would only retract to position 1.Can you please ask what was the sequence of events that may have led to the above issues? second question: the complaint description would seem to indicate a distal kink but from the lab evaluation no kink seemed to be present (see 1st photo below).However a kink below the sheath extender was observed (see 2nd photo below).Can you please clarify if the ¿needle bent at the first attempt¿ in the complaint description is for a distal kink/bend or for the kink below the sheath extender which was observed in the lab evaluation? if it is not for the kink below the sheath extender then can you please check if this kink was observed prior to shipping the device back to cook ireland? (ref.Att.¿re: (b)(4)_clarification required after lab evaluation (3rd attempt)¿).To date no reply has been received.If a reply is received in the future then the file will be updated accordingly.The following was noted after the lab evaluation on 12 feb 2021; a slight kink was observed on the distal end of the needle.A proximal kink below the sheath extender was observed.The needle was advanced with a lot of difficulty and a lot of dried blood was observed on the distal end of the needle.It is noted that during the first two lab evaluations the needle was unable to be advanced and retracted fully.This difficulty with advancing and retracting the needle is likely due to a combination of the distal kink and also the biological matter which was observed on the needle after advancement.An additional file was opened in relation to the proximal kink as it could not be linked to the complaint issue.Prior to distribution, all echo-hd-19-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 cirl a review of the manufacturing records for echo-hd-19-c of lot number c1406273 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 c1406273.The notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use: "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 biopsy site¿.There is evidence to suggest that the customer did not follow the instructions for use in relation to the use of the stylet (ifu0077-4).A definitive root cause could be attributed to user error as the stylet should not be partially removed prior to advancement of the needle into intended targeted site.As the stylet provides support to the needle for puncture this would have led to the distal kink.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.

Event Description

The device was re-evaluated on the (b)(6) 2021, confirmation was received that the user error and distal needle kink are related failures, therefore mdr ref #3001845648-2021-00008 has been cancelled as both failures are being investigated under this file.The investigation was concluded on the (b)(6) 2021, this supplement report is being submitted to include the investigation conclusions within section h.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11132128
• MDR Text Key: 244438100
• Report Number: 3001845648-2021-00007
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002535852
• UDI-Public: (01)10827002535852(17)201003(10)C1406273
• Combination Product (y/n): N
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2020
• Device Catalogue Number: ECHO-HD-19-C
• Device Lot Number: C1406273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1