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

Catalog Number ECHO-HD-3-20-C

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Needle could not be pushed out of the tube."as per cc from": the stylet push the needle out of the catheter.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? they finish the first puncture an retract the needle,then they want to retried the sample from the needle and notice the needle has complete detached from the handle.When the stylet insert, the needle was pushed out of the catheter 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))?no kink in the needle.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Stomach/ 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: n/a.If not with the device in question, how was the procedure performed and/or finished? they used a new needle.Was the device used in a tortuous position? n/a.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? fuji eus system.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? they finish the first puncture an retract the needle.Then they want to retried the sample from the needle and notice the needle has complete detached from the handle.When the stylet insert, the needle was pushed out of the catheter.Was the syringe used during the procedure, after the stylet was removed? no, the stylet was inside the needle and was rectrad after the needle was in position.Was difficulty experienced while retracting the needle? no.Was it possible to fully retract before removing the needle from the patient? yes.Was gaining access to the target site difficult? n/a.Was the endoscope in a flexed or twisted position at any time during the procedure? n/a.Was puncture of the target site difficult? n/a.Was the stylet partially removed when advancing into the target site? n/a.How many samples were obtained with this needle? it was the first sample.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? no kink.Is the patient known to be covid-19 positive? no.

Event Description

The investigation was concluded on the (b)(6) 2021, this supplement report is being submitted to include the investigation conclusions within section h.The investigation concluded no needle break noted based on information received, a re-assessment was carried out based on the investigation conclusions.The event no longer meet 's the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016.

Manufacturer Narrative

510(k) number: k142688.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿, the overall risk is low.Device evaluation: complaint device was not returned therefore a document based review will be performed.Clarification was requested as follows; ¿can you please confirm with the rep what exactly the complaint issue is as there is some conflicting information above?: a.The needle couldn¿t advance out of the sheath? b.The needle detached from the joint? c.The needle broke at the proximal end?¿ reply was received as follows; ¿the user could still pull the needles back into the catheter in the patient.To streak out the sample, the stylet was reinserted into the needle.The customer noticed that the needle at the top had come off the handle.The needle did not break off.It has probably come off the handle at the top.¿ further clarification was requested as follows: ¿would you mind requesting clarification as we believe there is still some confusion.Could i confirm the below information from the customer ¿the customer noticed that the needle at the top had come off the handle.The needle did not break off.It has probably come off the handle at the top.¿ the ¿needle at the top had come off the handle¿ is the customer referring to the stylet hub as per below photo separated from the handle? or the needle cannula in the second photo separated from the handle?¿ reply was received as follows: ¿it is the needle (cannula) and not the stylet that has come loose.This was only noticed after the procedure.The needle is not broken.¿ further clarification was requested as follows: ¿we just need to understand exactly what the issue was.We know that the needle did not break but do not understand what is meant by needle at the top had come off the handle or the needle (cannula) has come loose.I presume these refer to the same issue but if you could describe exactly what the issue was then this will really help the investigation.¿ reply was received as follows: ¿the glue point between handle and needle has loosened.When the needle was out of the patient and one held the cannula after under, the needle came out of the catheter.¿ prior to distribution, all echo-hd-3-20-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-3-20-c of lot number c1756719 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 c1756719.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".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0077-4).A definitive root cause for the customer complaint could not be determined from the available information.A possible root cause could be attributed to excessive force used when removing the device from the endoscope possibly due to tortuous position.This could have resulted in the inner handle becoming detached from the outer handle when the stylet was inserted into the device to streak out the sample outside the patient 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.

• 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: 10935625
• MDR Text Key: 251556768
• Report Number: 3001845648-2020-00907
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)230909(10)C1756719
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1756719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1