MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G34282
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k160229.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.It was originally indicated that the device involved in this complaint was being returned to cook ireland for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.A possible root cause will be updated when the device has returned for evaluation.Prior to distribution, all echo-hd-25-ebus-o-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 manufacturing records for lot number c1394546 did not reveal any issues which could have contributed to this complaint issue.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
No bleeding during the procedure.1st node right hilar (size 8mm) 2 passes 10 fans for each pass.2nd node : 4l left latero tracheal.1st pass /10 fans = no problem.During the second pass, dr (b)(6) felt something not normal.Video showed needle weakness.Procedure has been immediately stopped.The physician decided to remove all at the same time (needle+echoendo) to avoid echoendo damage and other incident risks.No part of the needle remained in patient body.At the end of the removal, when echoendo+needle were through i gel, needle has broken, broken part of it was blocked in i gel laryngeal mask.Removal of the i gel, then part of the needle broken retrieval.A new ebus needle was needed to continue the procedure.No problem with echo endo.No problem with needle insertion through echoendo channel.
Additional Manufacturer Narrative
Pma/510(k) # k160229.(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).I x echo-hd-25-ebus-o-c from lot number c1394546 was returned to cirl for evaluation.Upon evaluation the following was noted: there was no syringe returned.The stylet was in place.There was no needle exposure on return.The stylet and the needle match in length, there was no part of the needle missing.The needle advances and retracts without issue.There was not other functional issues with the device.The needle was broken distally.The customer complaint is considered to be confirmed as the broken needle was verified in the lab.A possible root cause may have been that the needle became broken by a hard node or possibly by hitting a tracheal ring.Prior to distribution, all echo-hd-25-ebus-o-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.The notes section of the instructions for use, ifu0109-7, which accompanies this device instructs the user to: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.A review of the manufacturing records for lot number c1394546 did not reveal any issues which could have contributed to this complaint issue.There is no evidence to suggest that this issue effects the entire lot # c1394546; upon review of complaints this failure mode has not occurred previously with this lot # c1394546.From the information provided, there have been no adverse effects to the patient as a result of 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 as the device was returned and evaluated.No bleeding during the procedure.1st node right hilar (size 8mm) 2 passes 10 fans for each pass.2nd node : 4l left latero tracheal.1st pass /10 fans = no problem.During the second pass, dr (b)(6) felt something not normal.Video showed needle weakness.Procedure has been immediately stopped.The physician decided to remove all at the same time (needle+echoendo) to avoid echoendo damage and other incident risks.No part of the needle remained in patient body.At the end of the removal, when echoendo+needle were through i gel, needle has broken, broken part of it was blocked in i gel laryngeal mask.Removal of the i gel, then part of the needle broken retrieval.A new ebus needle was needed to continue the procedure.No problem with echo endo.No problem with needle insertion through echoendo channel.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7033355
• Report Number: 3001845648-2017-00546
• Device Sequence Number: 19068577
• Product Code: FCG
• UDI-Device Identifier: 00827002342828
• UDI-Public: (01)00827002342828(17)200830(10)C1394546
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/14/2017

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: G34282
• Device Catalogue Number: ECHO-HD-25-EBUS-O-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR