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

Model Number G34785

Device Problem Break (1069)

Patient Problems Abdominal Pain (1685); No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

The 510(k) number; k142688.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Information relative to the actual event in (b)(6) hospital (b)(6).It currently contains an extract from the case study.One patient, who was referred to me from another facility, diagnosed with obstructive, jaundice secondary to pancreatic/ periampullary tumor.Patient underwent endoscopic ultra sound fine needle aspiration cytology (eus+fnac) under general, anesthesia (ga) in the month of (b)(6) 2018, which showed a pancreatic head mass lesion (neoplastic?) with dilated common bile duct and pancreatic duct fnac was done using echotip.Background and study aims endoscopic ultrasound guided fine needle aspiration (eus-fna) is widely performed to obtain pathological evidence from several parts of the body.Major complications of eus-fna are bleeding, pancreatitis, and abdominal pain.Needle fracture is a rare complication of eus-fna and only a few relevant reports are available.Here, we report a case of needle fracture during eus-fna using a needle with a side hole.A (b)(6) man underwent eus-fna of the uncinate process of the pancreas to confirm malignancy.A 20-gauge needle with a side hole was used to puncture the mass from the first part of the duodenum.The needle fracture occurred at the side hole during the third passage, and the fragment remained in the pancreas.Fortunately, the patient did not exhibit any symptoms due to the needle fragment.This case indicates that repeated puncture using the same needle with a side hole might increase risk of needle fracture during eusfna.It is important to inform clinicians about the potential risk of needle fracture, particularly given the increasing number of eus-fnas being performed.

Event Description

Information relative to the actual event in (b)(6) hospital (b)(6).It currently contains an extract from the case study.One patient, who was referred to me from another facility, diagnosed with obstructive, jaundice secondary to pancreatic/ periampullary tumor.Patient underwent endoscopic ultra sound fine needle aspiration cytology (eus+fnac) under general, anaesthesia (ga) in the month of (b)(6) 2018, which showed a pancreatic head mass lesion (neoplastic?) with dilated common bile duct and pancreatic duct fnac was done using echotip.Background and study aims endoscopic ultrasound guided fine needle aspiration (eus-fna) is widely performed to obtain pathological evidence from several parts of the body.Major complications of eus-fna are bleeding, pancreatitis, and abdominal pain.Needle fracture is a rare complication of eus-fna and only a few relevant reports are available.Here, we report a case of needle fracture during eus-fna using a needle with a side hole.A 61-year-old man underwent eus-fna of the uncinate process of the pancreas to confirm malignancy.A 20-gauge needle with a side hole was used to puncture the mass from the first part of the duodenum.The needle fracture occurred at the side hole during the third passage, and the fragment remained in the pancreas.Fortunately, the patient did not exhibit any symptoms due to the needle fragment.This case indicates that repeated puncture using the same needle with a side hole might increase risk of needle fracture during eusfna.It is important to inform clinicians about the potential risk of needle fracture, particularly given the increasing number of eus-fnas being performed.

Manufacturer Narrative

510 (k) number: k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4), cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington , indiana 47402-4195.Importer site establishment registration number: (b)(4).Device evaluation: the echo-hd-3-20-c device of lot number c1431977 involved in this complaint was not returned for evaluation.With the information provided, document based investigation was conducted.As per customer testimony the following information was received; how was the broken needle removed from the patient? a- as per the last update from the referring surgeon, the needle is not yet removed from the patient and is still lodged in his pancreas.Did the patient require to stay in the hospital? a- yes, after 3 days post procedure, patient developed severe acute pancreatitis and was admitted in another medical facility for almost 8 weeks.He may further require to stay in the hospital.Did the patient suffer any additional adverse reaction due to needle removal? a- as mentioned in response to the query 1 above, the needle is not yet removed from the patient¿s body.Additional information was received as follows: 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.The tip of the needle (distal end) broke during the procedure, causing retention of the broken tip in to the patients¿ pancreas (site of fnac).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.Not applicable.Please describe the size of the intended target site.Approximately 2.7x2.3 cm tumor in the head of pancreas.If not with the device in question, how was the procedure performed and/or finished? for the procedure only the echo tip pro core needle (wilson cook, ireland) -( lot noc143977; exp13-12-2020) (reference g34785; 20 g-echo-hd-3-20-c) was used.Was the device used in a tortuous position? no.Are images of the device or procedure available? yes.Was it damaged in packaging before removal? no.Was it damaged on removal from packaging? no.Was force required to remove the device? no.What is the endoscope manufacturer and model number that was used? linear endoscopic uiltrasound endoscope (olympus medical system, tokyo, japan); model no-gfuct260; serial (b)(4).Was the scope recently serviced / repaired? no.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? it came to my notice about 1-week post procedure, when i received a phone call from a referring surgeon that the was admitted at another facility with acute pancreatitis and his ct scan abdomen revealed the foreign body in the pancreas (in the region of head-area from where fnac was performed)-metal piece, part of needle tip from procore echotip needle which broke and was left behind in patient¿s pancreas during the fnac.What is the endoscope manufacturer and model number that was used with this device? linear endoscopic uiltrasound endoscope (olympus medical system, tokyo, japan); model no-gfuct260; serial (b)(4).Was difficulty experienced while retracting the needle? no.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 tim.E during the procedure? no was needle penetration of the targeted site difficult? no.Was the stylet fully in place inside the needle when advancing into the targeted site? yes, always.Was the stylet partially removed prior to advancement of needle? yes before each puncture i withdraw the stylet by few mm in to the needle before advancing the needle in to the target.How many biopsies/passes were obtained with use of this needle? 5 passes were taken.Did any section of the device detach inside the patient? yes, part of the needle tip of the procore needle echotip procore needle (wilson cook, ireland) -( lot noc143977; exp13-12-2020) (reference g34785; 20 g-echo-hd-3-20-c) got detached and was left behind in the pancreas of the patient.If kinked below the sheath extender, did they notice the kink before placing the device into the scope? not kinked.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.If the device is procore and it is kinked distally, is the kink at the notch / core trap? it was not kinked.As per customer testimony, "i did not find any abnormality in the needle tip after the last pass or rather any passes.We could expel the fna aspirate after each pass into the cytolyte bottle ( special solution to collect the cytology specimen).I hope this information helps in the investigation about the possibility of the needle tip breaking distal to the side hole." a definitive root cause for the customer complaint was determined.The investigation has determined that there is evidence to suggest that the user did not follow the instructions for use.As per instruction advises the user to "ensure the stylet is fully inserted when advancing the needle into the biopsy site." however as per additional information received the stylet was partially removed before each puncture by few mm in to the needle before advancing the needle into the target.The notes section of the instructions for use that accompanies this device instructs the user to "ensure the stylet is fully inserted when advancing the needle into the biopsy site." however as per additional information received the stylet was partially removed before each puncture by few mm in to the needle before advancing the needle into the target.There are evidence to suggest that the customer did not follow the instructions for use.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 device of lot# c1431977 did not reveal any discrepancies that could have contributed to this complaint issue.Complaint is confirmed based on the customer¿s testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up is being submitted as the investigation was amended.Information relative to the actual event in nmc speciality hospital (b)(6).It currently contains an extract from the case study.One patient, who was referred to me from another facility, diagnosed with obstructive, jaundice secondary to pancreatic/ periampullary tumor.Patient underwent endoscopic ultra sound fine needle aspiration cytology (eus+fnac) under general, anaesthesia (ga) in the month of (b)(6) 2018, which showed a pancreatic head mass lesion (neoplastic?) with dilated common bile duct and pancreatic duct fnac was done using echotip.Background and study aims endoscopic ultrasound guided fine needle aspiration (eus-fna) is widely performed to obtain pathological evidence from several parts of the body.Major complications of eus-fna are bleeding, pancreatitis, and abdominal pain.Needle fracture is a rare complication of eus-fna and only a few relevant reports are available.Here, we report a case of needle fracture during eus-fna using a needle with a side hole.A 61-year-old man underwent eus-fna of the uncinate process of the pancreas to confirm malignancy.A 20-gauge needle with a side hole was used to puncture the mass from the first part of the duodenum.The needle fracture occurred at the side hole during the third passage, and the fragment remained in the pancreas.Fortunately, the patient did not exhibit any symptoms due to the needle fragment.This case indicates that repeated puncture using the same needle with a side hole might increase risk of needle fracture during eusfna.It is important to inform clinicians about the potential risk of needle fracture, particularly given the increasing number of eus-fnas being performed.

Manufacturer Narrative

510 (k) number: k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.The echo-hd-3-20-c device of lot number c1431977 involved in this complaint was not returned for evaluation.With the information provided, document based investigation was conducted.As per customer testimony, "i did not find any abnormality in the needle tip after the last pass or rather any passes.We could expel the fna aspirate after each pass into the cytolyte bottle ( special solution to collect the cytology specimen).I hope this information helps in the investigation about the possibility of the needle tip breaking distal to the side hole." a definitive root cause for the customer complaint was not determined.The investigation has determined that there is evidence to suggest that the user did not follow the instructions for use.As per instruction advises the user to "ensure the stylet is fully inserted when advancing the needle into the biopsy site." however as per additional information received the stylet was partially removed before each puncture by few mm in to the needle before advancing the needle into the target.The notes section of the instructions for use ifu0077-4 that accompanies this device instructs the user to "ensure the stylet is fully inserted when advancing the needle into the biopsy site." however as per additional information received the stylet was partially removed before each puncture by few mm in to the needle before advancing the needle into the target.There are evidence to suggest that the customer did not follow the instructions for use (ifu0077-4).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 device of lot# c1431977 did not reveal any discrepancies that could have contributed to this complaint issue.Complaint is confirmed based on the customer¿s testimony.The risk was determined to be low risk (category iia).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: 7855019
• MDR Text Key: 119539401
• Report Number: 3001845648-2018-00415
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)201213(10)C1431977
• 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,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1431977
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91