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

Model Number	G53585
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # (12) 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 is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The completed customer complaint form was received on 07-feb-2019 with the complaint details.As per complaint form "eus was being performed to drain a cyst in the body of the pancreas.It was the first pass, it was not difficult to pass the scope or the needle to the site.The dr advanced the needle into the cyst and it would not retract back into the sheath.The dr removed the needle (with the needle coming out the front end of the sheath) very carefully.The procedure was completed using one of the same needles with no problem.".
Event or Problem Description
The completed customer complaint form was received on 07-feb-19 with the complaint details.As per complaint form "eus was being performed to drain a cyst in the body of the pancreas.It was the first pass, it was not difficult to pass the scope or the needle to the site.The dr advanced the needle into the cyst and it would not retract back into the sheath.The dr removed the needle (with the needle coming out the front end of the sheath) very carefully.The procedure was completed using one of the same needles with no problem.".
Additional Manufacturer Narrative
Pma/510(k) # (12) k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).The complaint device was not returned therefore a document based review will be performed.Prior to distribution, all echo-hd-19-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-19-c of lot number c1509400 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 c1509400.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use : "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Also, ¿intended use: this device is used with an ultrasound for fine needle biopsy, (fnb), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract".¿ there is evidence to suggest that the customer did not follow the instructions for use in relation to intended use.The failure of retraction of needle was concluded from the available information.A definitive root cause could not be determined from the available information.A possible cause could be attributed to off label use as the echo-hd-19-c device is intended for fine needle biopsy but it has been confirmed that it was used for cyst drainage.Complaint is confirmed based on the customer's testimony.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: 8398480
• Report Number: 3001845648-2019-00094
• Device Sequence Number: 313142
• Product Code: FCG
• UDI-Device Identifier: 00827002535855
• UDI-Public: (01)00827002535855(17)210611(10)C1509400
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 03/07/2019

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: 06/11/2021
• Device Model Number: G53585
• Device Catalogue Number: ECHO-HD-19-C
• Device Lot Number: C1509400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1