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

Catalog Number ECHO-19

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User felt obvious resistance retracting the stylet, and the stylet cannot be advanced into needle anymore.User then changed to another same device to complete the procedure.Complaint device was returned and evaluated on 06-oct-2021, proximal kink below the sheath extender was confirmed."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." 1.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))? n/a ( stylet issue) 2.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Bile duct 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.1 cm 4.If not with the device in question, how was the procedure performed and/or finished? with another same device to complete the procedure.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 endoscopic ultrasonography 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 stylet 13.Was difficulty experienced while retracting the needle? no.14.Was the syringe used during the procedure, after the stylet was removed? no.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? yes 20.How many biopsies/passes were obtained with use of this needle? no.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.25.If the device is procore and it is kinked distally, is the kink at the notch / core trap? n/a.

Event Description

A follow up mdr is being submitted because of investigation completion and update to investigation conclusions.

Manufacturer Narrative

Device evaluation: (b)(4) unit of lot c1822772 of echo-19 involved in this complaint was returned for evaluation, with the original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2021.Sheath extender able to advance and retract without issue.Needle able to advance and retract without issue.Distal end of the needle examined no issue observed.Needle was removed from the device and a proximal kink below the sheath extender was observed.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 c1822772 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 c1822772.The notes section of the instructions for use, 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".Also, ¿intended use: this device is used to sample targeted submuscosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is no evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the possibility that the device was over torqued during procedure leading to a kink below sheath extender.Additionally the device may have become kinked on attachment or detachment to scope.A capa has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction.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.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12746126
• MDR Text Key: 284817658
• Report Number: 3001845648-2021-00782
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)240422(10)C1822772
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1822772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2021
• Event Location: Hospital
• Date Manufacturer Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 76 KG