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

Model Number	G53585
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2017
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.Investigation pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
Clinician had trouble extending the needle out of the sheath on second pass.On visual "endoscopic" view he noticed the needle tip was bent so he removed the from the patient while the needle was still down the scope.On further investigation the needle was bent at the core trap.
Additional Manufacturer Narrative
Pma/510(k) # k142688.(b)(4).Exemption number: e2016031.(b)(4).Lab evaluation 1 x echo-hd-19-c from lot number c1384039 was returned to (b)(4) for evaluation.Upon evaluation of the returned device the following was noted: the stylet was returned in the device, there was no syringe returned.There was no needle exposure on return.The needle tip was missing from the device.The needle was returned removed from the device.Approximately 31.8cm where the needle is broken inside the device.The needle was broken in parts during the measurement of the needle.The entire returned needle measured approximately 146.3cm.The needle length should measure 1705mm, there is approximately 224.7mm missing of the needle.The customer complaint is confirmed by the verified pictures from the customer prior to return.The was needle broken both distally and proximally this was verified in the lab root cause: a possible root cause for this occurrence may have been die to a torturous anatomy or possibly the device was used on a hard lesion causing it to break.In this instance both breaks observed are not considered device failure modes as user has confirmed one was intentional to prevent damage to scope and one occurred on packaging.Additional information received the 15th november 2017:"i spoke to dr (b)(6).Nothing was left in the patient.As stated in the complaint form, the needle tip was visualised on endoscopic view so the scope and needle were removed.After removing from the patient the needle tip was again visualised and confirmed to be bent.They also noted that the needle had broken near the handle (outside the scope) so to prevent damage to the scope, they remove the needle in the reverse direction.Dr (b)(6) mentioned that the needle appeared to fracture again when the nurse coiled the needle to wrap it (for return).He said it was an odd needle and appeared to be brittle.Dr (b)(6) has used our needles for a number of years so is very familiar with them." 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 (b)(6).A review of the manufacturing records did not reveal any discrepancies that would have resulted in this complaint.The notes section of the instructions for use ifu0077-4 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".The tip of the needle and stylet are sharp and could cause injury to the patient or user if not used with caution.On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.From the information provided :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
This follow up mdr is being submitted to include the investigation conclusions.Clinician had trouble extending the needle out of the sheath on second pass.On visual endscopic view he noticed the needle tip was bent so he removed the from the patient while the needle was still down the scope.On further investigation the needle was bent at the core trap.

• 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: 7003112
• Report Number: 3001845648-2017-00516
• Device Sequence Number: 11225325
• Product Code: FCG
• UDI-Device Identifier: 00827002535855
• UDI-Public: (01)00827002535855(17)200731(10)C1384039
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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 Model Number: G53585
• Device Catalogue Number: ECHO-HD-19-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1