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 Code	Foreign Body In Patient (2687)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Upon evaluation of the returned device the following was noted: the broken part of the needle was returned in a falcon tube.There was no stylet returned, the syringe was attached to the device upon return.The top of the sheath was broken/damaged.The kink in the needle was at the sheath extender on return, most likely due to the conditions that the device was returned in, device was returned loose in a bag at mark 5.The first pass was in the wrong position possibly weakened the needle and then broke.The needle was broken at approximately 3cm from the tip.The sheath damage can be attributed to when the needle broke.The customer complaint is considered to be confirmed as needle broken prior to distribution, all echo-hd-19-a 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 devices of lot# c1313616 did not reveal any discrepancies that could have contributed to this complaint issue.From the information provided the patient to 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
Needle broken during the puncture.Cc form.Dr (b)(6) started a procedure of a bulbo choledocotomy, puncture of bile duct through the bulb.First time in wrong position, removed the needle.Second time, place the needle in straight position scope, bow the scope and use elevator to have a correct axes, try to push the needle and this was broken inside the scope.

• 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: 6540137
• Report Number: 3001845648-2017-00161
• Device Sequence Number: 864895
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)200110(10)C1313616
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K092359
• 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): 04/05/2017

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?: No
• 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: 05/03/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention