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

Model Number	G55738
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # 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 with the investigation conclusions.
Event or Problem Description
They started a punction with the needle 25 procore, they did a passage in the lesion and when they tried to reposition the mandrill in the sheath, it got blocked at the level of the junction needle / sheath.Impossible to reintroduce it to do a second passage in the lesion."as per complaint form": they opened the package and checked the needle all was good.They introduced the needle thought the operating channel without problem and they started a punction with the needle 25 procore, they did a passage in the lesion.They put material into the pot and flushed the needle and when they tried to reposition the mandril in the sheath, it got blocked at the level of the junction needle / sheath.Impossible to reintroduce it for doing a second passage in the lesion.Thy should take another punction needle.
Event or Problem Description
This follow up report is being submitted based on the conclusion of the investigation.They started a punction with the needle 25 procore, they did a passage in the lesion and when they tried to reposition the mandrill in the sheath, it got blocked at the level of the junction needle / sheath.Impossible to reintroduce it to do a second passage in the lesion."as per complaint form": they opened the package and checked the needle all was good.They introduced the needle thought the operating channel without problem and they started a punction with the needle 25 procore, they did a passage in the lesion.They put material into the pot and flushed the needle and when they tried to reposition the mandril in the sheath, it got blocked at the level of the junction needle / sheath.Impossible to reintroduce it for doing a second passage in the lesion.Thy should take another punction needle.
Additional Manufacturer Narrative
Pma/510(k) # k142688 (b)(4).Exemption number: e2016031 (b)(4).Lab evaluation: 1 x echo-hd-25-c of lot number c1216748 was returned to cook (b)(4) for evaluation.Upon evaluation, the device was returned in a plastic bag without the syringe.The stylet was fully removed upon return and there was no needle exposure.Cracking was noted at the sheath adjuster thumbscrew.There was no kinks on the stylet and there was some biological matter present.There was no cracking at the mlla or locking ring.A kink was observed below the sheath extender.This complaint will look at the kink in the needle and an additional complaint will be raised to address the cracking at the sheath adjuster thumbscrew.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However it is possible that the user applied excessive force when inserting/ removing the device from the scope after passes documents review: prior to distribution, all echo-hd-25-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 cook (b)(4).Ifu review: it may be noted that according to the instructions for use, ifu0077-4, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.A review of the manufacturing records for echo-hd-25-c of lot number c1216748 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1216748 upon review of complaints this failure mode has not occurred previously with this lot # c1216748.Summary: from the information provided, no adverse effects to the patient have been reported as a result of 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: 7182299
• Report Number: 3001845648-2018-00019
• Device Sequence Number: 16402942
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)190331(10)C1216748
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: G55738
• Device Catalogue Number: ECHO-HD-25-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1