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

Catalog Number ECHO-HD-3-20-C

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2023

Event Type  Injury  

Event Description

During a puncture the needle broke in 2 places.The 2 pieces are removed from the patient without negative impact.No negative consequences for the patient."as per cc form": during a puncture the needle broke in 2 places.The 2 pieces are removed from the patient without negative impact.No negative consequences for the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.1.Are images of the device or procedure available? no.3.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)?, no, the needle was in perfect condition.5.If the device is a procore needle, is the device damage located at the notch / core trap? yes the notch.If no, please specify where the damage is located: _____________________ 6.Was gaining access to the target site difficult?no transgastric-to-endoscope was straight transgastric-to-endoscope was straight.7.Was the device used in a tortuous position? no.8.Was puncture of the target site difficult? no.9.Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc.).Pancreas, tumor hard.10.Please describe the size of the intended target site.3-4cm.11.If not with the device in question, how was the procedure performed and/or finished? satisfactory sampling, because the needle breakage occurred on the 2nd pass.12.Was the device damaged in packaging prior to removal? no.13.Was the device damaged on removal from packaging? no.14.Was force required to remove the device? no.15.Did the patient require any additional procedures as a result of this event? no.16.What intervention (if any) was required? 18.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? no.20.What is the scope manufacturer and model number that was used? fujifilm eg-580ut.21.Was resistance felt while inserting the device through the scope? no.22.Was the scope recently serviced / repaired? constructive maintenance and french recommendation.23.When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction? on needle retraction.24.Was the syringe used during the procedure, after the stylet was removed? no.25.Was difficulty experienced while retracting the needle? no.26.Was it possible to fully retract the needle into the sheath before removing the device from the patient? yes.27.Was the endoscope in a flexed or twisted position at any time during the procedure? no.28.Was the stylet partially removed when advancing the needle into the target site? no, punction with the stylet.29.How many samples were obtained (passes completed) with this needle? 2 passes 30.Did any section of the device detach inside the patient? yes.If yes, please specify: 31.Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no.32.Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? no.33.When the needle tip was advanced into the target site was the distal scope position adjusted so as to strain or flex the needle?, no.34.If an ebus procedure did the needle tip hit the cartilage rings of the trachea?.

Manufacturer Narrative

Pma/510(k) # k210476.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 19-apr-2024.

Manufacturer Narrative

Pma/510(k) # k210476.Device evaluation: 1 unit of lot c2088355 of echo-hd-3-20-c was returned in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 15 january2024.The lab and lab attendance can be viewed in the ¿returned product ¿ notes¿ section.On evaluation of the devices the following observations were made: distal end of needle examined and observed to be broke approx.4 cm from the tip of sheath (ipe of ruler (ipe0402)), broken needle part returned separately, stylet returned separately to the device, sheath extender able to advance and retract without issue, needle handle able to advance and retract without issue.Manufacturing records: prior to distribution, all echo-hd-3-20-c devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for echo-hd-3-20-c of lot number c2088355 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the notes section of the instructions for use, ifu0077 which accompanies this device instructs the user to; "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).Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the needle tip of the device coming into contact with a hard lesion during the first successful pass as stated in the additional information, the puncture was made into a hard tumor 3-4 cm.Located in the pancreas.This could lead to the distal end of the needle break.Summary: complaint is confirmed based on visual and/or functional inspection.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
• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18485757
• MDR Text Key: 332568928
• Report Number: 3001845648-2024-00025
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)260906(10)C2088355
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C2088355
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2023
• Event Location: Hospital
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• 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
• Patient Outcome(s): Required Intervention