MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-22-EBUS-O-C

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #k160229.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User error-stylet partially removed when advancing into the targeted site ¿ related to (b)(4) cook internal complaint reference number.Was the stylet partially removed when advancing into the target site? yes.A section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.The physician stepped using the cook ebus procore needle and switched to an olympus needle instead according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) #k160229.This file was raised to capture "user error-stylet partially removed when advancing into the targeted site".Device evaluation: 1 unit of lot c1811801 of echo-hd-22-ebus-o-c was returned opened in its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the 10th june 2021.In summary the following results were observed in the lab evaluation: sheath extender able to advance and retract without any issue.Needle able to advance and retract without any issue.Distal end of needle examined and no issue observed.Stylet removed and examined, no issue observed.Stylet inserted back into device without any issue.No defect observed.Document review including ifu review: prior to distribution, all echo-hd-22-ebus-o-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-22-ebus-o-c of lot number c1811801 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 c1811801.The notes section of the instructions for use, ifu0109-6 which accompanies this device instructs the user to "ensure the stylet is fully inserted when advancing the needle into the biopsy site".There is evidence to suggest that the customer did not follow the instructions for use in relation to the use of the stylet (ifu0109-6-6).As per additional information provided stylet was partially removed when advancing into the target site.Image review: n/a.Root cause review: a definitive root cause could be attributed to user error.As per additional information provided stylet was partially removed when advancing into the target site.The instructions for use, which accompanies this device instructs the user to "ensure the stylet is fully inserted when advancing the needle into the biopsy site".Summary: complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.From additional information provided: "they didn¿t stopped the procedure, only got the other device during the same procedure.There was no significant delay, maybe 5 minutes.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.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12133369
• MDR Text Key: 280905717
• Report Number: 3001845648-2021-00540
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002342818
• UDI-Public: (01)10827002342818(17)240320(10)C1811801
• 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
• Report Date: 09/03/2021

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 Expiration Date: 03/20/2024
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1811801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/27/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1