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

Catalog Number	ECHO-HD-25-C
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.On evaluation of the returned device, it was noted that the stylet was returned but was not in place and was badly damaged.The needle couldn¿t be advanced fully.The handle of the device was dismantled in the lab to show that the needle was crumpled proximally in the handle.The customer complaint was confirmed as the handle was crumpled.Prior to distribution, all echo-hd-25-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 record for echo-hd-25-c device of lot number c1252725 did not reveal any discrepancies which could have contributed to this complaint report.From the information provided, no adverse effects to the patient have been reported as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations, "physician used a 25g core needle in suspicious head of pancreas mass.Upon initial insertion of needle into mass, nurse noted stylet popped out of needle approximately one to two inches.While physician was moving needle in and out, nurse was attempting to retrieve the stylet in a slow pull manner.She observed extreme difficulty removing the stylet and eventually noticed a coiling or curling of the stylet.Upon final removal of the stylet, it was noted it would be impossible to reinsert into the needle.The stylet was completely deformed.Eventually when she attempted to coil it to return to manufacturer, it broke." device returned and the needle was confirmed to be crumpled in the handle.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6352632
• Report Number: 3001845648-2017-00062
• Device Sequence Number: 650075
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)190715(10)C1252725
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2017

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-25-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 02/23/2017
• Patient Sequence Number: 1