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

Catalog Number ECHO-HD-19-C

Device Problem Material Twisted/Bent (2981)

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

Event Date 06/20/2022

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

The needle would not go into the sheath "as per cc form": the needle would not go into the sheath complaint device was returned and evaluated on 11-jul-2022: visual inspection: - distal end of needle examined and kink observed at notch of needle - stylet returned not fully inserted but stylet able to be fully re-inserted.Functional inspection: - sheath extender able to advance and retract with no issue.- needle able to advance with no issue.- attempted to retract needle into sheath but unable to retract fully due to kink.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.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))? n/a, no knik.3.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no please specify if yes device is being tested , from olympus.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? yes.If no, please specify where the damage is located: _____________________ 6.Was gaining access to the target site difficult? no.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.).Stomach.A.If the lungs, which lymph node was being targeted? e.G.4r, 11r, 12l etc.10.Please describe the size of the intended target site.5cm.11.If not with the device in question, how was the procedure performed and/or finished? echo-hd-19-c.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? no.17.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 18.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? yes.19.If yes, please specify what was observed and where on the device it was observed.Device is being tested , from olympus.20.What is the scope manufacturer and model number that was used? gf-uct-180 21.Was resistance felt while inserting the device through the scope? no.22.Was the scope recently serviced / repaired? no.23.When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction? needle or 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? yes.26.Was it possible to fully retract the needle into the sheath before removing the device from the patient? no.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.29.How many samples were obtained (passes completed) with this needle? one.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.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.Device evaluation: 1 unit of lot c1919866 of echo-hd-19-c was returned opened in the original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 11 july 2022.The returned device lab findings and observations can be referred through the attached files.The needle handle was observed to be detached from inner handle document review including ifu review: prior to distribution, all echo-hd-19-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-19-c of lot number c1919866 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 c1919866.The notes section of the instructions for use, ifu0077, which accompanies this device instructs the user to inspect the device prior to use: "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 biopsy site¿.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0077.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.A possible root cause could be attributed to the lesion, it is possible the actual lesion was hard leading to the distal end of the needle to kink.Summary: complaint is confirmed as failure was verified in the laboratory.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 follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 29-jul-2022.

• 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: 15063569
• MDR Text Key: 304799674
• Report Number: 3001845648-2022-00435
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002535852
• UDI-Public: (01)10827002535852(17)250307(10)C1919866
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-19-C
• Device Lot Number: C1919866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/20/2022
• Event Location: Hospital
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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