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 Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

Pma 510(k) number: k142688.(b)(4).Information pertaining to section contact office as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Device has been returned and evaluated, however additional information is required to complete investigation.A follow up mdr will be submitted on completion of investigation.

Event Description

When using the punction needle for the 2nd passage, it was impossible to pass again the mandril in the needle because the needle disconnected from its sheath.Consequences: delay, risk of aes with needle, extra cost because a 2nd needle had to be used.A second needle was used to finish the procedure.

Manufacturer Narrative

510(k) number: k142688 (b)(4).Exemption number: e2016031 (b)(4) additional information received the 18jan 2018: "can you ask the rep the following questions: what additional procedures were carried out due to this occurrence? anesthesia was the patient brought back for another procedure or was the initial procedure prolonged? the time to open the new needle if so, how long was the procedure prolonged and why? 2 / 3 minutes what adverse effects did the patient experience due to this occurrence? nothing" lab evaluation: 1 x echo-hd-3-20-c from lot number c1371180 was returned to cook (b)(4) for evaluation.Upon evaluation the following was noted the device was returned in it¿s original packaging.There was a bloodied syringe returned.The stylet was returned outside of the device.There was no needle exposure; there was a slight bend in the tip of the needle.The needle was broken approximately 137.6cm at the proximal end near the sheath extender.The needle does not retract back into the sheath once advances.The needle in the handle measures approximately 326cm.There is a kink in the sheath proximally lines up with the break in the needle.The device was dismantled in the lab to insure no part of the needle was missing.The stylet was passed through the sheath successfully.All parts of the needle were accounted for.The customer complaint is confirmed as the needle broken was verified in the lab.A potential root cause for this event may have been that the excessive force was applied causing the needle to break 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 cook (b)(4).A review of the manufacturing record for echo-hd-3-20-c device of lot number c1371180 did not reveal any discrepancies which could have contributed to this complaint report.There is no evidence to suggest that this issue affects the entire lot # c1371180; upon review of complaints this failure mode has not occurred previously with this lot # c1371180 the notes section of the instructions for use, ifu0077-4, and precautions section: that accompanies this device instructs the user to ¿ensure the stylet is fully inserted when advancing the needle into the biopsy site, when targeting multiple sites, replace device for each site.¿ on review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.From the information provided, the patient did not require any additional procedures due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up mdr is being submitted due to the conclusion into this investigation.When using the punction needle for the 2nd passage, it was impossible to pass again the mandril in the needle because the needle disconnected from its sheath.Consequences: delay, risk of aes with needle, extra cost because a 2nd needle had to be used.A second needle was used to finish the procedure.

• 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
• MDR Report Key: 7198906
• MDR Text Key: 97492240
• Report Number: 3001845648-2018-00027
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)200623(10)C1371180
• 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
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2018
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80