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

Catalog Number	ECHO-HD-19-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in this complaint is an echo-hd-19-a device of lot# c1111767.This echo device was received with the stylet outside the device and with the needle fully retracted in the sheath.The stylet that was returned with the device was noted not to be the correct stylet for this device, as it did not have a bevel and incorrect stylet cap.The sheath of the device was examined and a kink was noted below the sheath extender when the sheath extender was positioned at reference mark 3.The distal sheath tip was examined and noted be damaged (perforated) at approx.4cm from the sheath tip.On evaluation of the device resistance was experienced when advancing the echo needle out of the sheath due to the distal needle catching on the wall of the sheath at the distal end and torn open longitudinally from approx.4cm to 2.8cm from the sheath tip.The needle extension was examined and was confirmed to be broken.The extended broken needle measured 3.6cm, which indicated that approx.3.7cm of the distal needle tip was missing.It was confirmed by the rep that the broken off needle tip was discarded by the nurse.The customer complaint was confirmed based on customer testimony.However, as the returned stylet was not a bevelled stylet (which comes with the device), this would have made puncturing with the needle into a target site more difficult.As the conditions of device usage cannot be replicated during the laboratory evaluation, it is not possible to conclusively determine the root cause of this complaint.Based on the investigation findings and the number of checks completed throughout the manufacturing process which revealed no issues which could have contributed to this complaint report.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 for echo-hd-19-a device of lot# c1111767 did not reveal any discrepancies that could have contributed to this complaint issue.The instructions for use, ifu0050-1, advises the user to ¿visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
When doctor tried to puncture the cyst,needle bent and did not penetrate the cyst.When the device was returned it was noted the needle was broke which is a malfunction precedence for this product family.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5448933
• Report Number: 3001845648-2016-00037
• Device Sequence Number: 10849515
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)180518(10)C1111767
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: ECHO-HD-19-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2015
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2015
• Initial Report FDA Received Date: 02/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR