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 Problem Foreign Body In Patient (2687)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The needle was used to take 2 samples of a pancreatic mass as per the ifu.On the third pass with the procore 20 needle the pancreatic mass was punctured and then the stylet was removed.When the doctor began to pull back slightly on the needle to commence fanning he felt no resistance and noted the needle was not moving on the ultrasound image (269656).He immediately removed the scope from the patient and when the scope was withdrawn the shaft of the needle was still protruding from the patients mouth.A nurse grabbed the needle shaft and pulled it out of the patient.As the end of the needle came out of the patients mouth the nurse suffered a needle stick injury to the arm from the end of the needle (271124).The procedure was completed with another procore 20 needle.There were no reported adverse events to the patient.The nurse underwent needle stick injury protocol.

Event Description

The needle was used to take 2 samples of a pancreatic mass as per the ifu.On the third pass with the procore 20 needle the pancreatic mass was punctured and then the stylet was removed.When the doctor began to pull back slightly on the needle to commence fanning he felt no resistance and noted the needle was not moving on the ultrasound image (269656).He immediately removed the scope from the patient and when the scope was withdrawn the shaft of the needle was still protruding from the patients mouth.A nurse grabbed the needle shaft and pulled it out of the patient.As the end of the needle came out of the patients mouth the nurse suffered a needle stick injury to the arm from the end of the needle (271124).The procedure was completed with another procore 20 needle.There were no reported adverse events to the patient.The nurse underwent needle stick injury protocol.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # k142688.The echo-hd-3-20-c device of lot number c1594386 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.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 relevant manufacturing records (c1594386) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c1594386.The notes section of the instructions for use, 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.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to hard lesion, and flexed scope position as per information provided.Complaint is confirmed based on the image.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The nurse pulled the broken needle out of the patient and got a needle stick injury to the arm.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The needle was used to take 2 samples of a pancreatic mass as per the ifu.On the third pass with the procore 20 needle the pancreatic mass was punctured and then the stylet was removed.When the doctor began to pull back slightly on the needle to commence fanning he felt no resistance and noted the needle was not moving on the ultrasound image (269656).He immediately removed the scope from the patient and when the scope was withdrawn the shaft of the needle was still protruding from the patients mouth.A nurse grabbed the needle shaft and pulled it out of the patient.As the end of the needle came out of the patients mouth the nurse suffered a needle stick injury to the arm from the end of the needle (271124).The procedure was completed with another procore 20 needle.There were no reported adverse events to the patient.The nurse underwent needle stick injury protocol.

• 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: 8854182
• MDR Text Key: 153089532
• Report Number: 3001845648-2019-00384
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)220313(10)C1594386
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1594386
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/08/2019
• Event Location: Hospital
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention