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

Catalog Number ECHO-HD-22-C

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

K142688 - 510 k #.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The lab evaluation was completed on 09-nov-2020 and revealed and distal needle breakage.Complaint now reportable to fda reporting precedence for 'distal needle breakage'.The investigation is still on going.Per rep (b)(6) 2020 upon opening the package, it was noticed that the needle was bent and was partially sticking out.The procedure was successfully completed with another device of the same type.

Manufacturer Narrative

K142688 - 510 k #.1 unit of lot c1732011 of echo-hd-22-c was returned opened in its original packaging.The device involved in the complaint was evaluated in the laboratory on 09 nov 2020.The distal end of the needle was found to be broken and distal end of the sheath damaged.A proximal kink was observed below the sheath extender.The stylet was unable to be inserted fully most likely due to the distal needle break.Clarification was requested as follows; ¿please see below photos of different failures observed on the returned complaint device during lab evaluation earlier today.The complaint description states ¿upon opening the package, it was noticed that the needle was bent and was partially sticking out¿.Can you please clarify the following; 1.Which of the photos above showing the different failures observed during the lab evaluation relate to the complaint description ¿needle was bent and was partially sticking out¿? 2.Were all of the failures which were observed during the lab evaluation observed by the user before the device was shipped back to cirl? any further information related to the users observations would be really beneficial to the completion of the investigation.¿ reply was received as follows; ¿sorry for my delay in getting back to you on this.Unfortunately, i am not able to provide further clarification on the questions from the investigators.¿ prior to distribution, all echo-hd-22-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-c of lot number c1732011 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 c1732011.The notes section of the instructions for use, ifu0077-4, 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¿.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0077-4).A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.The amount of damage observed here would commensurate with this packaged device coming into contact with a significant external force/squeeze that damaged the contents as follows; the area of the package where distal needle is located became damaged (both needle and sheath as observed).And the same forces may have led to the stylet being pushed back out slightly from the device as observed.Same force led to a pull on the sheath extender section and therefore leading to the proximal kink was observed below the sheath extender.Or it is possible also this kink occurred during returns for evaluation.The stylet was unable to be inserted fully most likely due to the distal needle break as it stops just at this location.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, this observation was made prior to patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The investigation was concluded on the 25-jan-2021, this supplement report is being submitted to include the investigation conclusions within section h.

• 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: 10966945
• MDR Text Key: 234112836
• Report Number: 3001845648-2020-00918
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002557366
• UDI-Public: (01)10827002557366(17)230511(10)C1732011
• 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: 01/25/2021

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
• Device Operator: No Information
• Device Expiration Date: 05/11/2023
• Device Catalogue Number: ECHO-HD-22-C
• Device Lot Number: C1732011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2020
• Event Location: Home
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1