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

Catalog Number ECHO-HD-19-C

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

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

Event Date 10/08/2021

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

A member of staff attempted to use one your products in a procedure this morning however it was faulty and they had to use another one to complete the procedure.They were unable to retract the needle during the procedure however afterwards they did manage to retract it with considerable force."as per cc form": customer unable to retract needle during the case.Managed this eventually after using considerable force.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.(n/a) according to the initial reporter, the patient did not experience any adverse effects due to this occurrence (n/a).

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 31-jan-2022.

Manufacturer Narrative

Pma/510(k) # k142688.Device evaluation: complaint device was not returned therefore a document based review will be performed.Lab evaluation: n/a document review including ifu review prior to distribution, all echo-hd-19-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-19-c of lot number c1847693 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 c1847693.The notes section of the instructions for use, ifu0077-4, 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 (ifu0077-4).Image review: n/a root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to a possible distal kink that occurred during handling of the device during sample collection resulting in the difficulty retracting the needle into the sheath.A possible root cause could also be attributed flexed endoscope position.This potentially could have caused the needle to kink distally resulting in it being unable to retract into the sheath another possible root cause could be attributed to a potentially difficult target site or a hard lesion which could have potentially led to the needle kinking distally and cause the retraction difficulties experienced.This potentially could have caused the needle to kink distally resulting in it being unable to retract into the sheath.Summary: complaint is confirmed based on customers testimony.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12751585
• MDR Text Key: 280141923
• Report Number: 3001845648-2021-00788
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002535852
• UDI-Public: (01)10827002535852(17)240706(10)C1847693
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-19-C
• Device Lot Number: C1847693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2021
• Event Location: Hospital
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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