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

Catalog Number	ECHO-HD-19-C
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The echo-hd-19-c device involved in this complaint was returned for evaluation.This echo device was received with the needle un-retracted and exposed from the sheath of the device.The needle was bent at the tip.The stylet was returned with the device and in-situ.The sheath was examined and no kinks were visible below the sheath extender, when the sheath extender was positioned at reference mark 3.5 or along the sheath length.On evaluation of the device the needle could be advanced and retracted confirming the needle was not broken.This distal needle tip was examined under the microscope and it was confirmed to be bent/folded over.The needle could not retract fully into the sheath as the needle tip catches on the sheath tip.The customer complaint was confirmed as the device was returned with the needle partially exposed from sheath extender and could not fully be retracted.A possible cause of this complaint is that the distal needle tip bent due to product handling during the procedure or specimen retrieval/preparation.This would result in the difficulties experienced by the customer in retracting the needle.Since the conditions of device usage cannot be replicated in the laboratory it is not possible to conclusively determine the root cause of this complaint.Prior to distribution, all echo devices are subjected to functional checks and 100% visual inspection to ensure integrity of the product.These inspections and functional checks are outlined in internal procedures in place at (b)(4).A review of the manufacturing records for echo devices of lot# c1187562 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1187562 ; upon review of complaints this failure mode has not occurred previously with this lot # c1187562.The notes section of the instructions for use ifu0077-3 that accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".According to the initial reporter, the patient did not experience any adverse effects due to this occurrence and no section of the device remained inside the patient¿s body.The physician used another new needle.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
After the first pass, it was noted that there was a bend on the very tip of the needle and it was not possible to retract the needle into the sheath.Another echo device was used to complete the procedure.

• 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: 5772086
• Report Number: 3001845648-2016-00175
• Device Sequence Number: 315210
• Product Code: FCG
• UDI-Device Identifier: 00827002535855
• UDI-Public: (01)00827002535855(17)190106(10)C1187562
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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): 06/08/2016

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ECHO-HD-19-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2016
• Initial Report FDA Received Date: 07/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1