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

Catalog Number ECHO-HD-22-C

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).The customer complaint is considered to be confirmed based on customer testimony.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.A definitive root cause for the customer complaint could not be determined , possible causes may be due to excessive force.As the lot number was not provided, a review of manufacturing instructions could not be complete.Prior to distribution, all echo 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 could not be conducted as there was no product lot number attached.The notes section of the instructions for use that accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".The tip of the needle and stylet are sharp and could cause injury to the patient or user if not used with caution.On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.From the information provided :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

As reported to customer relations, "during an eus, they went down into the patient.They punctured as they were going to take a sample as part of the procedure.The tech went to remove the stylet and it was really difficult to pull out.There is a little handle tip on the back-end of the stylet and it popped off due to the force being used to try and remove the stylet.At which point, the tech tried to pull out the stylet with greater force and the tech ended up stabbing himself with the stylet in his hand.The tech was sent to occupational health to address his injury to his hand.In regards to the eus procedure that was being performed on that patient, it's unknown at this time how that procedure was completed.The district manager is following up to gather more information from the facility.Updated follow up information provided by the dm after his conversation with the tech on 06oct2017: it was actually the patient end of the stylet that the tech stabbed himself in the hand with.The dm indicated the tech reported there were three passes with this device.The first two passes were fine.However, right after the third pass is when the difficulty occurred.

Manufacturer Narrative

Pma/510(k) # k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).Additional information received on 10-nov-2017 confirming: tech was treated for scratch from the stylet on the needle.The customer complaint is considered to be confirmed based on customer testimony.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.A definitive root cause for the customer complaint could not be determined , possible causes may be due to excessive force causing the stylet cap to become dislodged.As the lot number was not provided, a review of manufacturing instructions could not be complete.Prior to distribution, all echo 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 could not be conducted as there was no product lot number attached.The notes section of the instructions for use ifu0077-4 that accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".The tip of the needle and stylet are sharp and could cause injury to the patient or user if not used with caution.On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.From the information provided: 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

This follow up mdr is being submitted due to additional information received.As reported to customer relations, "during an eus, they went down into the patient.They punctured as they were going to take a sample as part of the procedure.The tech went to remove the stylet and it was really difficult to pull out.There is a little handle tip on the back-end of the stylet and it popped off due to the force being used to try and remove the stylet.At which point, the tech tried to pull out the stylet with greater force and the tech ended up stabbing himself with the stylet in his hand.The tech was sent to occupational health to address his injury to his hand.In regards to the eus procedure that was being performed on that patient, it's unknown at this time how that procedure was completed.The district manager is following up to gather more information from the facility.Updated follow up information provided by the dm after his conversation with the tech on 06oct2017: it was actually the patient end of the stylet that the tech stabbed himself in the hand with.The dm indicated the tech reported there were three passes with this device.The first two passes were fine.However, right after the third pass is when the difficulty occurred.

• 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 Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6997898
• MDR Text Key: 90961185
• Report Number: 3001845648-2017-00507
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/06/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/10/2017
• 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 Outcome(s): Other; Required Intervention