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

Catalog Number ECHO-HD-22-EBUS-P

Device Problems Break (1069); Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # k160229.Investigation is still pending, a follow up mdr will be submitted once the investigation is concluded.

Event Description

During the punction the needle broke."as per cc form": the needle broke during the procedure.Lab evaluation complete on 15-dec-2021: distal break observed.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))? no.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? no.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.Was gaining access to the target site difficult? no.Was the device used in a tortuous position? no.Was puncture of the target site difficult? no.Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc.).Lunges.If the lungs, which lymph node was being targeted? e 10l.Please describe the size of the intended target site.6mm.If not with the device in question, how was the procedure performed and/or finished? with cook ebus 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? no.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? no.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? pentax eb-19ju10.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? needle or on needle retraction.Was the syringe used during the procedure, after the stylet was removed? no.Was difficulty experienced while retracting the needle? no.Was it possible to fully retract the needle into the sheath before removing the device from the patient? n/a, yes, no.Was the endoscope in a flexed or twisted position at any time during the procedure? n/a,yes,no.Was the stylet partially removed when advancing the needle into the target site? n/a,yes,no.How many samples were obtained (passes completed) with this needle? did any section of the device detach inside the patient? n/a, yes, 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.Investigation is still pending, a follow up mdr will be submitted once the investigation is concluded.

Event Description

Supplemental follow up report is being submitted due to lab evaluation completion on 15-dec-2021: distal break observed.

Manufacturer Narrative

Pma/510(k) # k160229.Device evaluation 1 unit of lot c1864544 of echo-hd-22-ebus-p was returned opened not in its original packaging.It should be noted that this file is related to another complaint file.Three devices were returned to cirl in the same packaging for (b)(4) (mdr ref # 3001845648-2021-00879) and (b)(4) (mdr ref # 3001845648-2021-00880).It was impossible to determine which of the devices were related specifically to which of the two prs.As a result, two of the devices were selected for pr (b)(6) and the third device selected for (b)(6).The device involved in the complaint was evaluated in the laboratory on 15 dec 2021.The distal end of the needle returned was found to be broken approx.2.5cm from tip of sheath.Clarification was also requested as follows; ¿three devices were returned to cirl for evaluation in relation to pr 348715 and pr 348716.As you can see from the photos below 5 broken needle parts from the distal sections of the needles were returned along with the three devices.Can you please clarify the following; the complaint description of both prs states that the needles broke during punction.Am i correct in assuming that the distal end of the needles broke inside the patient during the puncture attempts and the broken needle parts were retrieved from the patient by the doctor during the procedure? if this is a correct assumption can you please ask how the broken needle parts were retrieved e.G.Forceps? if this is an incorrect assumption can you please ask the circumstances of how the distal ends of the needle broke?¿ reply was received as follows; ¿yes, these needle pieces recovered with a forceps.¿ document review including ifu review prior to distribution, all echo-hd-22-ebus-p 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 of lot number c1864544 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 c1864544.The notes section of the instructions for use, ifu0060-4, which accompanies this device instructs the user to inspect the device prior to use for any damage: "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 (ifu0060-4).A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.Although it was advised target site was not difficult, it is possible the actual lesion was hard leading to the distal end of the needles to break during the puncture attempts complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.It was confirmed that the broken needle parts were retrieved from the patient with a forceps.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due additional information recieved 02-feb-2022 that broken needles were removed using forceps during the procedure file updated to serious injury requiring intervention.Investigation completed 04-feb-2022 and an update to the investigation conclusions.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 13023881
• MDR Text Key: 283587619
• Report Number: 3001845648-2021-00880
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002534084
• UDI-Public: (01)10827002534084(17)240903(10)C1864544
• 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,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-P
• Device Lot Number: C1864544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• 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