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

Model Number G34282

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

510(k) number: k160229.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Dr (b)(6) performed an ebus.At the end of the procedure it was noted that the tip of the needle had sheared off.The procedure was not a difficult one.A ct was performed and the tip was in the node.A bronchoscope was performed and the tip was retrieved.

Manufacturer Narrative

510 (k) number; 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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Dr.(b)(6) performed an ebus.At the end of the procedure it was noted that the tip of the needle had sheared off.The procedure was not a difficult one.A ct was performed and the tip was in the node.A bronchoscope was performed and the tip was retrieved.

Manufacturer Narrative

510 (k) number; 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.This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.1 x echo-hd-25-ebus-o-c was returned to cirl for evaluation.The needle was observed to be broken at the distal end.Complaint is confirmed as the failure was verified during lab evaluation.From the information provided ¿scope was flexed initially so it had contact with the tracheal wall.It is believed the needle tip must have broken off as scope was being advanced.¿ 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 echo-hd-25-ebus-o-c device of lot number c1327235 did not reveal any discrepancies that could have contributed to the issue.The instructions for use, 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".As per information provided, ¿patient coughed needle tip up and it was then retrieved from the trachea.¿ ¿a bronchoscope was performed and the tip was retrieved.¿ root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.From the information provided ¿scope was flexed initially so it had contact with the tracheal wall.It is believed the needle tip must have broken off as scope was being advanced.¿ complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.Initial report details: dr.(b)(6)performed an ebus.At the end of the procedure it was noted that the tip of the needle had sheared off.The procedure was not a difficult one.A ct was performed and the tip was in the node.A bronchoscope was performed and the tip was retrieved.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8184440
• MDR Text Key: 131008961
• Report Number: 3001845648-2018-00613
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002342828
• UDI-Public: (01)00827002342828(17)200217(10)C1327235
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2020
• Device Model Number: G34282
• Device Catalogue Number: ECHO-HD-25-EBUS-O-C
• Device Lot Number: C1327235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2018
• Event Location: Hospital
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention