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 Fracture (1260); Retraction Problem (1536)

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As per originally reported in (b)(4) ¿ ¿the physician did 2 sessions successfully.However, at the 3rd puncture, he recognized that something was wrong with the sheath.The sheath and needle disconnected from patient end to luer lock part.So he used another procore 20, but 2nd needle happened again.Finally he finished the case with 2 core samples.¿ the 2nd complaint device was returned and evaluated in the lab on 04-mar-2022-- visual inspection: needle returned with distal end of needle exposed.Slight damage observed on sheath just below the sheath extender.Functional inspection: sheath extender able to advance and retract with slight difficulty.Needle able to advance with no issue but unable to retract.Needle removed from the device and proximal needle break observed just below the sheath extender.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.

Manufacturer Narrative

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

Event Description

This follow up mdr is being submitted to capture the lab re-evaluation conducted on 19-apr-2022: luer locks examined and no issue observed.

Manufacturer Narrative

Pma/510(k) # k210476.Device evaluation: 2 units of lot c1879548 of echo-hd-3-20-c were returned opened in its original packaging under pr (b)(4).With the information provided, a physical examination and document based investigation was conducted.This file is related to complaint file pr (b)(4).Lab evaluation: the devices involved in this complaint was evaluated in the laboratory on 04 march 2022.The returned device lab findings and observations can be referred through the attached files.A proximal break below the sheath extender was observed.A proximal kink below the sheath extender of the second device and this will be examined in another file pr (b)(4).The devices were re evaluated on the 19 april 2022.Luer locks of pr (b)(4) and pr (b)(4) examined and no issue observed.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 c1879548 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 c1879548.The notes section of the instructions for use, ifu0077, 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).Image review n/a.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.A possible root cause could be attributed to observed needle breaking below the sheath extender which led to the difficulties reported, a possible root cause could be attributed to device being damaged during the second puncture or when entering the device into the scope for the third pass.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.Summary: 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.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 14-jul-2022.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13974453
• MDR Text Key: 298135988
• Report Number: 3001845648-2022-00194
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)241020(10)C1879548
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2022

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-3-20-C
• Device Lot Number: C1879548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 03/14/2022; 03/14/2022
• Supplement Dates FDA Received: 05/18/2022; 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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