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

Model Number	G34785
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Dr.(b)(6) got some sample in the first, second penetration but on the third 3cm of needle was broken.
Event or Problem Description
Dr.(b)(6) got some sample in the first , second penetration but on the third 3cm of needle was broken.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿distal needle breakage'.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Pma/510(k) #k142688.Device evaluation: the echo-hd-3-20-c device of lot number c1610470 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 04dec2019.Refer to attachments (b)(4)_lab attendance and (b)(4)_lab evaluation notes for lab attendance and notes.The returned device lab examination findings and observations can be referred through attached photos (ref att.'(b)(4)_lab decon evaluation photos').There was three failure modes observed.The needle tip was returned separately.The three failure modes are as follows: a distal kink at the notch area.A break at the distal end of the needle.A kink approximately 1.2cm from tip of sheath.It is likely that the initial failure mode was the distal kink and thus the needle tip broke and sheath kinked.All failures observed are linked.Document review: prior to distribution, all echo-hd-3-20-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 relevant manufacturing records (c1610470) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1610470.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0077-4).Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible cause could be attributed to the distal part of the needle coming into contact with a hard part of the patient anatomy leading to a distal kink and possibly in turn led to the needle breaking when outside the patient.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, 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.

• 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: 9436783
• Report Number: 3001845648-2019-00678
• Device Sequence Number: 2353386
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)220502(10)C1610470
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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 Expiration Date: 05/02/2022
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1610470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1