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

Catalog Number	ECHO-HD-25-EBUS-O-C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k number= k160229.This echo device was received with the needle fully retracted into the sheath.The stylet was fully outside the device and noted to be kinked at approx.2-3mm from the distal stylet tip.There was a kink visible below sheath extender when the sheath extender was positioned at reference mark 0.A further bend/kink was visible at approx.6 mm from the distal end of the advanced needle tip.It was possible to fully advance and retract the needle without resistance during the laboratory evaluation.The sheath tip was noted to be buffed and without any damage/defects.This distal needle was examined under the microscope and approximately 2-3 mm confirmed to have been broken off and missing.The customer complaint was confirmed as the device was returned with approximately 2-3 mm of the distal needle tip broken-off.The most likely cause of this complaint is that the needle tip kinked during the several attempts of advancing into the targeted site (second node), which in turn resulted in needle tip to break upon removal of the needle from the lesion.A needle can kink/bend due to product handling during the procedure.The needle kink/bend may also be attributed to patient anatomy if the lesion being punctured was a hard lesion or if the endoscope was used in a tortuous anatomy.The kink below the sheath extender most likely occurred during product handling and transportation back to (b)(4).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 (b)(4).A review of the manufacturing records for echo-hd-25-ebus-o-c devices of lot# c1177881 did not reveal any discrepancies that could have contributed to this complaint issue.The precautions section of the instructions for use ifu0109-4 that accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.It also mentions in the precautions section; ¿when targeting multiple sites, replace device for each site.¿ 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 or Problem Description
During the procedure, part of the needle broke while in use, this occurred in the lymph node while removing the stylet.The broken distal tip was left in the patient and a second device was used to complete the procedure.

• Brand Name: ECHOTIP® PROCORE¿ HD ENDOBRONCHIAL BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5575905
• Report Number: 3001845648-2016-00094
• Device Sequence Number: 10891926
• Product Code: FCG
• UDI-Device Identifier: 00827002342828
• UDI-Public: (01)00827002342828(17)181202(10)C1177881
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ECHO-HD-25-EBUS-O-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2016
• Initial Report FDA Received Date: 04/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63