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 Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

K142688 - 510 k #.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Answers to additional questions received on 14-oct-2020.As per answer to q16.Was it possible to fully retract before removing the needle from the patient? they responded 'as the tip got bend, just kept the tip distally to scope tip and removed whole scope along with the needle out from patient and retracted needle in to the sheath' above answer to questions indicates that the needle was not able to be retracted before removing from patient and is therefore reportable for fda reporting precedence of 'non retraction of needle' distal bevel tip,bended while performing procedure to the patient in second pass.Eus guided fnb procedure, first pass got good tissue sampling, at the second pass needle got blunt during puncture, taken out needle from the scope and used olympus ezy shot for additional sampling and complete the procedure successfully.Was a kink or bend identified on the device? where is this located on the device (handle end (proximal end) or patient end (distal end) or multiple kinks along the length device? was the kink or bend identified on the device within the packaging, prior to use or post use? no.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.Pancreatic head mass.Please describe the size of the intended target site.2.5x2 cm.If not with the device in question, how was the procedure performed and/or finished? procedure performed using olympus ezyshot needle.Was the device used in a tortuous position? slightly bend position.Are images of the device or procedure available? device pictures are available.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? for complaints occurring during use (once in contact with endoscope) also ask: no.What is the endoscope manufacturer and model number that was used? olympus 190 series.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? at the time of puncturing the sight.Was the syringe used during the procedure, after the stylet was removed? initial puncture done using syringe , second puncture needle got bend not able to pass.Was difficulty experienced while retracting the needle? yes.Was it possible to fully retract before removing the needle from the patient? as the tip got bend,just kept the tip distally to scope tip and removed whole scope along with the needle out from patient and retracted needle in to the sheath.Was gaining access to the target site difficult? no.Was the endoscope in a flexed or twisted position at any time during the procedure? transduodenal puncture was done,scope was in little bend position.Was puncture of the target site difficult? no.Was the stylet partially removed when advancing into the target site? no.How many samples were obtained with this needle? one pass done and second pass tip got bend.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 return to the manufacturer? 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, kink taken place distally at the notch.Is the patient known to be covid-19 positive? no.

Event Description

This is a final report.The investigation was concluded on 11-dec-2020.Results and conclusions are in section h of report answers to additional questions received on 14-oct-2020.As per answer to q16.Was it possible to fully retract before removing the needle from the patient? they responded 'as the tip got bend, just kept the tip distally to scope tip and removed whole scope along with the needle out from patient and retracted needle in to the sheath' above answer to questions indicates that the needle was not able to be retracted before removing from patient and is therefore reportable for fda reporting precedence of 'non retraction of needle' distal bevel tip,bended while performing procedure to the patient in second pass.Eus guided fnb procedure, first pass got good tissue sampling, at the second pass needle got blunt during puncture, taken out needle from the scope and used olympus ezy shot for additional sampling and complete the procedure successfully.1.Was a kink or bend identified on the device? where is this located on the device (handle end (proximal end) or patient end (distal end) or multiple kinks along the length device? was the kink or bend identified on the device within the packaging, prior to use or post use? no.2.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).A.If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.Pancreatic head mass.3.Please describe the size of the intended target site.2.5x2 cm.4.If not with the device in question, how was the procedure performed and/or finished? procedure performed using olympus ezyshot needle.5.Was the device used in a tortuous position? slightly bend position.6.Are images of the device or procedure available? device pictures are available.7.Was the device damaged in packaging before removal? no.8.Was the device damaged on removal from packaging? no.9.Was force required to remove the device? for complaints occurring during use (once in contact with endoscope) also ask: no.10.What is the endoscope manufacturer and model number that was used? olympus 190 series.11.Was the scope recently serviced / repaired? no.12.Was resistance felt while inserting the device through the scope? no.13.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? at the time of puncturing the sight.14.Was the syringe used during the procedure, after the stylet was removed? initial puncture done using syringe ,second puncture needle got bend not able to pass.15.Was difficulty experienced while retracting the needle? yes.16.Was it possible to fully retract before removing the needle from the patient? as the tip got bend,just kept the tip distally to scope tip and removed whole scope along with the needle out from patient and retracted needle in to the sheath.17.Was gaining access to the target site difficult? no.18.Was the endoscope in a flexed or twisted position at any time during the procedure? transduodenal puncture was done,scope was in little bend position.19.Was puncture of the target site difficult? no.20.Was the stylet partially removed when advancing into the target site? no.21.How many samples were obtained with this needle? one pass done and second pass tip got bend.22.Did any section of the device detach inside the patient? no.23.If the device was kinked below the sheath extender, was the kink observed before return to the manufacturer? no.24.Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no.25.Was there difficulty in attaching or detaching the device of the leur lock to the scope? no.26.If the device is a procore, is the kink located distally at the notch / core trap? yes kink taken place distally at the notch.27.Is the patient known to be covid-19 positive? no.

Manufacturer Narrative

K142688 - 510 k #.Device evaluation.1 unit of lot c1543497 of echo-hd-3-20-c was returned opened in its original packaging.Clarification was requested as follows; inrelation to the answer provided for q 16 below, can the customer please be asked to confirm if the needle was able to be retracted before removing the needle from the patient? 16.Was it possible to fully retract before removing the needle from the patient? as the tip got bend, just kept the tip distally to scope tip.And removed whole scope along with the needle out from patient and retracted needle in to the sheath¿ reply was received as follows; ¿yes the tip was completely retracted from the patient, no foreign body was there at the punctured site, as the tip got bend, needle could not able to retract completely in to the sheath, by keeping the tip out of the sheath, and also at the tip of the scope, needle was carefully removed along with the scope¿ lab evaluation.The device related to this occurrence underwent a laboratory evaluation on 09 oct 2020.The returned device lab findings and observations can be referred through the attached files.A slight kink was observed at the distal end of the needle around the notch area the tip of the needle was examined, and no issue observed.Clarification was requested as follows; ¿below please find the photo provided in the file of the complaint device and also a photo of the complaint device when it was evaluated in the lab at cook ireland.As you can see from the above photos above there is a very obvious and severe kink in the first photograph but in the photo of the device from the lab evaluation at cook ireland there is no sign of this severe kink.Is it possible that the distal end of the needle was straightened before returning the device to cook ireland?¿ reply was received as follows; ¿with due concern over the above subject, when the needle is taken back into the sheath it may have come into the normal shape.When they have given the needle to me it was sterilised pack i checked it and send it back to company.¿ the above would seem to indicate that the slight kink observed during the lab evaluation was the same kink encountered by the user prior to shipping the device back to cirl.Document review including ifu review.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 c1543497 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 c1543497.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).Root cause review.A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.Although it has been advised target site was not difficult, it is possible the actual lesion was hard leading to the distal end of the needle to kink.It was indicated that an initial puncture was made and as per complaint form it states that the needle got blunt during puncture which might possibly have been due to hard lesion.Another possible root cause could also be attributed to the endoscope in a flexed position as indicated in the additional information causing the needle to kink distally.Summary.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 10829965
• MDR Text Key: 272479698
• Report Number: 3001845648-2020-00861
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)210926(10)C1543497
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1543497
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 68