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 Foreign Body In Patient (2687)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Needle tip broken off in the lymph node.However the tip could be recovered.N both interventions the physician tried to puncture the lymph node 4 (1st intervention: 4r / 2nd: 4l).As pulled back the needle he realized that the has gone.In both the needle could be recovered under massive effort.Lab evaluation complete on: 09 may 2022.(b)(4) device 1.Visual inspection: broken needle tip returned separately (approx.0.4cm in length).Functional inspection: sheath extender able to advance and retract with no issue.Needle able to advance and retract with no issue.(b)(4) device 2.Visual inspection: proximal needle kink observed below sheath extender.Distal end of needle examined and no issue observed.Stylet removed from device and examined and no issue observed.Functional inspection: sheath extender able to advance and retract with slight difficulty.Needle able to advance and retract with slight difficulty.Attempted to re-insert stylet into device but would not pass kink below sheath extender.(b)(4).Visual inspection: broken needle tip returned separately (approx.0.5cm in length).Functional inspection: sheath extender able to advance and retract with no issue.Needle able to advance and retract with no issue.Note: one device observed with a broken needle tip relates to (b)(4).A section of the device did remain inside the patient¿s body.1st: retrieved with forceps.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.For all complaints, ask: are images of the device or procedure available? n/a, yes, no.[feind, andreas] yes.They are inside the return box.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))? n/a, handle end, patient end [feind, andreas] n/a.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.[feind, andreas] 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.[feind, andreas] n/a.If the device is a procore needle, is the device damage located at the notch / core trap? n/a, yes, no.[feind, andreas] yes.If no, please specify where the damage is located: was gaining access to the target site difficult? n/a, yes, no.[feind, andreas] no.Was the device used in a tortuous position? n/a, yes, no.[feind, andreas] no.Was puncture of the target site difficult? n/a, yes, no.[feind, andreas] no.Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc.).[feind, andreas] lungs.If the lungs, which lymph node was being targeted? e.G.4r, 11r, 12l etc.[feind, andreas] 1st case: 4r / 2nd case: 4l.Please describe the size of the intended target site.[feind, andreas] 1st 1.8 cm / 2nd 2 cm.If not with the device in question, how was the procedure performed and/or finished? [feind, andreas] new echo-hd-22-ebus-p-c in both cases.Was the device damaged in packaging prior to removal? n/a, yes, no.[feind, andreas] no.Was the device damaged on removal from packaging? n/a, yes, no.[feind, andreas] no.Was force required to remove the device? n/a, yes, no.[feind, andreas] no.Did the patient require any additional procedures as a result of this event? n/a, yes, no.[feind, andreas] in the 2nd case it is probable that the patient needs another examination if the probes do no cover a determining result.What intervention (if any) was required? [feind, andreas] 2nd ebus examination.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 [feind, andreas] if it will happen, it will be another day.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? n/a, yes, no.[feind, andreas] 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? [feind, andreas] pentax eb-19j-10u.Was resistance felt while inserting the device through the scope? n/a, yes, no [feind, andreas] no.Was the scope recently serviced / repaired? n/a, yes, no.[feind, andreas] no.When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction? [feind, andreas] needle retraction.Was the syringe used during the procedure, after the stylet was removed? n/a, yes, no [feind, andreas] no ¿ slow pull technique.Was difficulty experienced while retracting the needle? n/a, yes, no.[feind, andreas] no.Was it possible to fully retract the needle into the sheath before removing the device from the patient? n/a, yes, no.[feind, andreas] yes.Was the endoscope in a flexed or twisted position at any time during the procedure? n/a,yes,no.[feind, andreas] no.Was the stylet partially removed when advancing the needle into the target site? n/a,yes,no.[feind, andreas] yes.How many samples were obtained (passes completed) with this needle? [feind, andreas] 1st: 2 stations (12l / 7) / 2nd: 1 station (7).Did any section of the device detach inside the patient? n/a, yes, no.If yes, please specify: [feind, andreas] yes.In both cases the tip of the needle detached.Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? n/a, yes, no.[feind, andreas] no.Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? n/a, yes, no.[feind, andreas] 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? n/a, yes, no.[feind, andreas] no.If an ebus procedure did the needle tip hit the cartilage rings of the trachea? [feind, andreas] no.

Manufacturer Narrative

Pma/510(k) # k160229.Device evaluation: 3 units of lot c1872362 of echo-hd-22-ebus-p-c were returned opened in their original packaging under (b)(4).2 units were returned in the same plastic tray and tyvec packaging and the third device was returned in a separate plastic tray and tyvec packaging.Lab evaluation: the devices involved in the complaint were evaluated in the laboratory on 09 may 2022.The distal end of the needle returned under pr (b)(4) -device 1 was found to be broken.The broken needle tip returned was approx.0.4cm in length.This failure is investigated under this file (b)(4).A proximal needle kink was observed below the sheath extender under (b)(4) device 2.Distal end of needle examined and no issue observed.As it was confirmed that this kink was not observed prior to shipping the device back to cirl, it can be concluded that the kink came about as a result of transport returns and therefore no additional pr is required to be opened.The distal end of the needle returned under (b)(4) was found to be broken.The broken needle tip returned was approx.0.5cm in length.This failure is investigated under (b)(4).(reference mdr#3001845648-2022-00306) 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 c1872362 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has 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 c1872362.The notes section of the instructions for use, ifu0110 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).Image review: n/a.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 break.Summary: 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.The broken needle tip was recovered from the patient using 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 to the completion of the investigation and an update to the investigation conclusions on the 30-may-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: 14486069
• MDR Text Key: 292478072
• Report Number: 3001845648-2022-00297
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002342795
• UDI-Public: (01)10827002342795(17)240929(10)C1872362
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-C
• Device Lot Number: C1872362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Male