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

Model Number	G34279
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #k160229.Complaint device was not returned therefore a document based review will be performed.Prior to distribution, all echo-hd-22-ebus-p-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-22-ebus-p-c of lot number c1515647 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1515647.The notes section of 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".There is no evidence to suggest that the customer did not follow the instructions for use.The failure of needle broken was concluded from the available information.A definitive root cause could not be determined from the available information.As there was no additional information shared a possible root cause is difficult to determine but could be attributed to the needle breaking after hitting the tracheal rings during the procedure as indicated by the complaint description.Complaint is confirmed based on the customer's testimony.The tip of the needle has been retrieved from the patient with a forceps.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The needle broke on the trachea during puncture, the tip has been retrieved with a forceps.
Event or Problem Description
This follow up report is being submitted due to the return and evaluation of the device involved in this event.Initial report details: the needle broke on the trachea during puncture, the tip has been retrieved with a forceps.
Additional Manufacturer Narrative
Pma/510(k) #k160229.1 unit of lot c1515647 of echo-hd-22-ebus-p-c was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation.The needle was found to be broken distally.Prior to distribution, all echo-hd-22-ebus-p-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-22-ebus-p-c of lot number c1515647 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1515647.The notes section of 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".There is no evidence to suggest that the customer did not follow the instructions for use.The failure of needle broken was observed in the laboratory.A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.As there was no additional information shared a possible root cause is difficult to determine but could be attributed to the needle breaking after hitting the tracheal rings during the procedure as indicated by the complaint description.Complaint is confirmed as the failure was verified in the laboratory.The tip of the needle has been retrieved from the patient with a forceps.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 9121907
• Report Number: 3001845648-2019-00492
• Device Sequence Number: 11397426
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)210702(10)C1515647
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2021
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1515647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention