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

Catalog Number ECHO-HD-19-A

Device Problems Fracture (1260); Material Perforation (2205); Structural Problem (2506)

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

Event Date 04/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The doctor inserted the echo-hd-19-a through the scope.He adjusted the angle and punctured using handle.However, the handle was not pressed well and the needle did not come out either.The nurse pulled the echo-hd-19-a out and found that sheath was broken.The end of the sheath was hanging broken.The doctor guessed the cause of the sheath being broken - when he pushed the handle, the needle pierced the bent sheath.So sheath was broken.They used the new 19g needle of boston.Did any section of the device remain inside the patient body? no did the patient require any additional procedures due to this occurrence? no did the product cause or contribute to the need for additional procedure(s)? no were there any adverse effects on the patient due to this occurrence? no did the product cause or contribute to the adverse effect(s)? no for all complaints, ask: 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))? patient end.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.Please describe the size of the intended target site.Unknown.If not with the device in question, how was the procedure performed and/or finished? ezshot3 22g.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? gf-uct260 (olympus).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 first puncturing.Was the syringe used during the procedure, after the stylet was removed? syringe was not used in this case.Was difficulty experienced while retracting the needle? needle did not come out.Was it possible to fully retract before removing the needle from the patient? yes.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? yes.Was the stylet partially removed when advancing into the target site? no.How many samples were obtained with this needle? nothing.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.

Event Description

The device was returned and evaluated on the 16-jun-2021, this supplement report is being submitted to reflect the lab evaluation within section d & h.

Manufacturer Narrative

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

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation 1 echo-hd-19-a device of unknown lot number was returned without the original packaging.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2021.On evaluation of the device the sheath extender was able to retract without any issue.Needle was able to advance with a lot of difficulty.No issue observed with distal end of needle.Slight damage observed on distal end of sheath.Needle retracted from device and needle break observed below the sheath extender.Stylet was not returned.Document review as the lot number of the complaint is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all echo-hd-19-a devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The notes section of the instructions for use, ifu0050-2 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¿.There is no evidence to suggest that the customer did not follow the instructions for use.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 excessive force which can be applied when trying to get the needle out of the scope during advancement.This could potentially have led to the damage observed on distal end of sheath.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated 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 HIGH DEFINITION ULTRASOUND ACCESS 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: 11846995
• MDR Text Key: 281029027
• Report Number: 3001845648-2021-00394
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K092359
• 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,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-19-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 04/22/2021; 04/22/2021
• Supplement Dates FDA Received: 07/15/2021; 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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