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

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

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Encounter a problem with the procores: in fact, it has been 3 examinations that the needles have been twisted to such an extent that i can no longer put them back into the endoscope, so much so that i had to take the endoscope out with the needle out.Fortunately, this had no consequences for the patients, but it consumes more needles, slows down the process, and is at risk for the patients.As per cc form": dr verkaeren sent an email to inform us she noted needles deformation during 3 different ebus procedures.No more details at the moment.' rep update 11/07/2022: i met dr.(b)(6) on thursday following 3 incidents encountered with our ebus procore the 3 batch numbers used were c1933079 (pr (b)(6))- c1928790 (pr (b)(6)) - c1933639 (pr (b)(6)) with the echo endo pentax eb19-j10u the problems on these 3 needles were identical.They twisted at the first puncture.The plication was at the level of the lateral bevel of the needle.After discussion, it seems that the stylet is not completely put into the needle during the puncture.What would explain this fold.No declaration of material would have been made to the pharmacy.His initial email was a request for information following the 3 problems encountered consecutively.I went over each step of the procedure and the proper use of the needle with the pulmonologist.She keeps me informed of these next procedures.Note: user error, stylet partially removed confirmed (b)(6) 2022.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.Are images of the device or procedure available? no.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))? the needle was bent at the bevel.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.Please specify if yes.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? n/a, yes, no.If the device is a procore needle, is the device damage located at the notch / core trap? yes.If no, please specify where the damage is located: ,cap trap.Was gaining access to the target site difficult? no.Was the device used in a tortuous position? no more than usual.Was puncture of the target site difficult? no.Please describe the anatomical location of the intended target site "bronchus ".If the lungs, which lymph node was being targeted? no precise information.Please describe the size of the intended target site.Different on the 3 needles.If not with the device in question, how was the procedure performed and/or finished? used another needle.Was the device damaged in packaging prior to removal? no.Was the device damaged on removal from packaging? no.Was force required to remove the device? no.Did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? nothing.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? no.If yes, please specify what was observed and where on the device it was observed.What is the scope manufacturer and model number that was used? see the form.Was resistance felt while inserting the device through the scope? no.Was the scope recently serviced / repaired? no.When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction? during the puncture.Was the syringe used during the procedure, after the stylet was removed? yes.Was difficulty experienced while retracting the needle? yes.Was it possible to fully retract the needle into the sheath before removing the device from the patient? no.Was the endoscope in a flexed or twisted position at any time during the procedure? no.Was the stylet partially removed when advancing the needle into the target site? yes.How many samples were obtained (passes completed) with this needle? 0.Did any section of the device detach inside the patient? no.If yes, please specify:.Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no.Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? no.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.If an ebus procedure did the needle tip hit the cartilage rings of the trachea? no.

Manufacturer Narrative

Pma/510(k) # k160229 device evaluation complaint device is not returned therefore a document based review will be performed.It should be noted that this file is related to another two complaint files.For details of the other investigations please refer to pr 367608 (report reference number 3001845648-2022-00440) and pr 368128 (report reference number 3001845648-2022-00446).Clarification was requested as follows; ¿customer has reported the issue for 3 different ebus procedures, could you please request for their lot numbers and specific rpns? if they belong to different lots we will have to open 2 additional complaints.It would also be great if they are able to share the date of events for the 3 procedures and if they were in 3 different patients¿ reply was received as follows; ¿i met dr.Verkaeren on thursday following 3 incidents encountered with our ebus procore the 3 batch numbers used were c1933079 - c1928790 - c1933639 with the echo endo pentax eb19-j10u the problems on these 3 needles were identical.They twisted at the first puncture.The plication was at the level of the lateral bevel of the needle.After discussion, it seems that the stylet is not completely put into the needle during the puncture.What would explain this fold.No declaration of material would have been made to the pharmacy.His initial email was a request for information following the 3 problems encountered consecutively.I went over each step of the procedure and the proper use of the needle with the pulmonologist.She keeps me informed of these next procedures.¿ document review including ifu review prior to distribution, all echo-hd-22-ebus-p-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-p-c of lot number c1928790 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 c1928790.The notes section of the instructions for use, ifu0110-7 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" and "ensure the stylet is fully inserted when advancing the needle into the target site".There is evidence to suggest that the customer did not follow the instructions for use in relation to the use of the stylet (ifu0110-7) as per update from rep ¿after discussion, it seems that the stylet is not completely put into the needle during the puncture.What would explain this fold¿ root cause review a definitive 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 stylet provides support to the needle for puncture this would have led to the distal end of the needle to kink as indicated in q.2 of the additional questions.It has been confirmed by the rep that re-training with the pulmonologist has taken place as per following statement ¿i went over each step of the procedure and the proper use of the needle with the pulmonologist.¿ 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

Supplemental report is being submitted due to the completion of the investigation.

• 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: 15077252
• MDR Text Key: 304718021
• Report Number: 3001845648-2022-00445
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002342795
• UDI-Public: (01)10827002342795(17)250401(10)C1928790
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1928790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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