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

Model Number G34785

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2018

Event Type  malfunction  

Manufacturer Narrative

510 (k) number: k142688.(b)(4).Information pertaining to section as follows: (b)(4).Importer site establishment registration number: (b)(4).Document review: prior to distribution, all echo-hd-3-20-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.Ifu review: the notes section of the instructions for use, (b)(4), 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" and "ensure the stylet is fully inserted when advancing the needle into the biopsy site".There is evidence to suggest that the customer did not follow the instructions for use ((b)(4)).Root cause review: the failure of needle broken was concluded from the available information.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to user error as the stylet should not be partially removed prior to advancement of the needle into intended targeted site.As the target site was detailed as moderately hard tumour the user error could have caused the needle fracture.Summary 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.

Event Description

During intervention after needle was introduced they pulled it off and it was bent.While trying to straight it back (as it should be), the needle broke."as per complaint form": during a puncture of a pancreatic tumor.The needle is broken at the distal end of the procore system.The needle is broken outside the patient during the extraction of cytological samples.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 8128238
• MDR Text Key: 129783340
• Report Number: 3001845648-2018-00563
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)210629(10)C1514893
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1514893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2018
• Event Location: Hospital
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1