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	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On evaluation of the returned device, the sheath of the device was examined and no kinks were noted below the sheath extender when the sheath extender was positioned at reference mark 3 and the needle extender at reference mark 0.The device was returned with 30mm of the stylet not inserted and the needle of the device fully retracted.The stylet was removed and no damage was evident on the component.The needle of the device was returned with 2.6cm of the distal end of the needle broken off, this was returned with the device in a separate container.A kink on the sheath was noted 3cm from the distal end.It was noted by the research & development engineer that the kink is most likely secondary and not the cause of the issue.Damage was also observed at the end of the sheath and was it stated by the research & development engineer that it is possible that this occurred when the needle broke.The customer complaint was confirmed as the needle was broken.As the conditions of use cannot be replicated during the laboratory evaluation, it is not possible to conclusively determine the root cause for the needle breakage.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 device of lot# c1194790 did not reveal any discrepancies that could have contributed to this complaint issue.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
It was reported that the doctor tried to prick into the cyst, the needle bent and broke.The broken piece was recovered.A new needle was used.

• 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: 5995922
• Report Number: 3001845648-2016-00278
• Device Sequence Number: 18930432
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)190125(10)C1194790
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/08/2016

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?: 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: 08/31/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 10/04/2016
• 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