MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-22-EBUS-O-C

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

Surgeon tried to perform fnb as usual, and the needle cannot retrieved back into catheter after procedure.The needle was found bended after surgeon took it outside the scope.

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 lab evaluation on (b)(6) 2022 and receipt of additional questions received (b)(6) 2022 lab evaluation complete on (b)(6) 2022: visual inspection: distal end of needle examined and distal tip observed protruding from sheath at distal end.Needle removed from device and distal needle break observed 2.5cm from distal tip.Proximal kink observed below the sheath extender.1.Are images of the device or procedure available? yes 2.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? middle of the needle around 2.5mm 3.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no please specify if yes.4.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? no 5.If the device is a procore needle, is the device damage located at the notch / core trap? no if no, please specify where the damage is located: around 2.5cm from distal end 6.Was gaining access to the target site difficult? yes 7.Was the device used in a tortuous position? no 8.Was puncture of the target site difficult? yes 9.Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc.).A.If the lungs, which lymph node was being targeted? r4 10.Please describe the size of the intended target site.Large than 1cm node, not really hard.11.If not with the device in question, how was the procedure performed and/or finished? surgeon continued and finished the procedure with olympus vizishot 2 needle.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? yes 15.Did the patient require any additional procedures as a result of this event? no 16.What intervention (if any) was required? na 17.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? surgeon continued and finished the procedure with olympus vizishot 2 19g needle.18.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? only the needle bends 19.If yes, please specify what was observed and where on the device it was observed.20.What is the scope manufacturer and model number that was used? olympus bf-p290 21.Was resistance felt while inserting the device through the scope? no problem during inserting the device tho the scope 22.Was the scope recently serviced / repaired? n/a 23.When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction? needle retraction , unable to retract back to 0 position.24.Was the syringe used during the procedure, after the stylet was removed? no 25.Was difficulty experienced while retracting the needle? yes, very difficult.26.Was it possible to fully retract the needle into the sheath before removing the device from the patient? no , the needle stay at 3cm mark during remove from device because unable to retract back to 0 27.Was the endoscope in a flexed or twisted position at any time during the procedure? just flexed with the patient anatomy not twisted 28.Was the stylet partially removed when advancing the needle into the target site? no 29.How many samples were obtained (passes completed) with this needle? zero 30.Did any section of the device detach inside the patient? no if yes, please specify: 31.Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no difficulties for locking the sheath and needle.32.Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? sightly difficult to remove the device from accessory channel port since the needle unable to retrieve to 0 position 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 needle tip advancement has been perform , since r4 is straight forward position.34.If an ebus procedure did the needle tip hit the cartilage rings of the trachea? no.

Manufacturer Narrative

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

Manufacturer Narrative

Pma 510k # k210476 device evaluation 1 unit of lot c1853877 of echo-hd-22-ebus-o-c was returned opened in its original packaging.Lab evaluation the device involved in the complaint was evaluated in the laboratory on (b)(6) 2022.Distal end of needle examined and distal tip observed protruding from sheath at distal end needle removed from device and distal needle break observed 2.5cm from distal tip.Proximal kink observed below the sheath extender.Clarification was requested as follows; ¿was the proximal kink below the sheath extender observed when the device were being sent back to cook ireland?¿ reply was received as follows; ¿the proximal kink should be caused by transport return¿.Document review including ifu review prior to distribution, all echo-hd-22-ebus-o-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-ebus-o-c of lot number c1853877 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 c1853877.The notes section of the instructions for use, ifu0109-7 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 (ifu0109-7) root cause review a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.As per images and video provided the distal end of needle appears to be kinked, this subsequently led to the failures observed during the lab evaluation most likely caused by a build-up of pressure and resulting in the following: distal tip observed protruding from sheath at distal end and distal needle break observed 2.5cm from needle tip.The failure mode of distal needle kink was chosen as the video and images attached show when the needle was advanced a distal kink was evident at that time.If the needle had been broken at that time, then the needle would not have been able to be retrieved back into the sheath ¿almost fully¿ which is the way it arrived back to cirl.A possible root cause for the initial failure of the distal kink could be attributed to difficult access to target site and the device being used in a flexed position as indicated in the additional information causing the needle to kink which in turn would have led to the needle retraction issue.This in turn could also have resulted in the difficulty removing the device from the scope as per q.33 of the additional questions since the needle was unable to retrieve fully into the sheath.Summary complaint is confirmed based on the customer's testimony, video and images provided.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplementary report being submitted due to the completion of the investigation on the 22-sep-2022.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD 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: 15190668
• MDR Text Key: 305242515
• Report Number: 3001845648-2022-00504
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002342818
• UDI-Public: (01)10827002342818(17)240728(10)C1853877
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2022

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: Health Professional
• Device Expiration Date: 07/28/2024
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1853877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 07/12/2022; 07/12/2022
• Supplement Dates FDA Received: 09/08/2022; 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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 Sex: Male