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

Catalog Number ECHO-19

Device Problem Off-Label Use (1494)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Puncture cannula is blunt."as per cc form": physician tried to puncture the lymphknot.But needle was blunt, so it was impossible.Needle was retracted and another one was used to progress in procedure.Note: off-label use, target site was the lungs a section of the device did not remain inside the patient¿s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))? n/a, were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, 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 if the device is a procore needle, is the device damage located at the notch / core trap? n/a if no, please specify where the damage is located: _____________________ was gaining access to the target site difficult? yes was the device used in a tortuous position? n/a was puncture of the target site difficult? yes please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc.).A.If the lungs, which lymph node was being targeted? e.G.4r, 11r, 12l etc.Please describe the size of the intended target site.[feind, andreas] oversized if not with the device in question, how was the procedure performed and/or finished?[feind, andreas] another echo-19 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?[feind, andreas] none was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? yes if yes, please specify what was observed and where on the device it was observed.[feind, andreas] the needle is blunt.What is the scope manufacturer and model number that was used?[feind, andreas] pentax eg-387 0 utk was resistance felt while inserting the device through the scope? no.Was the scope recently serviced / repaired? n/a.When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction?[feind, andreas] puncture of the lymph node.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? yes.Was the endoscope in a flexed or twisted position at any time during the procedure? n/a was the stylet partially removed when advancing the needle into the target site? yes.How many samples were obtained (passes completed) with this needle? [feind, andreas] none.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?[feind, andreas] n/a.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This follow up mdr is being submitted to capture the lab evaluation: complaint device was returned and evaluated on 21-oct-2021, dull needle tip and proximal kink below sheath extender noted.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation: 1 unit of lot c1831796 of echo-19 was returned opened in its original packaging.The device involved in these complaints were evaluated in the laboratory on 19 may 2021.The sheath extender able to advance and retract.Needle able to advance and retract with difficulty.Proximal kink below the sheath extender observed needle tip examined and found to be slightly dull.Prior to distribution, all echo-19 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-19 of lot number c1831796 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 c1831796.The notes section of the instructions for use, ifu0101-1 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 evidence to suggest that the customer did not follow the instructions for use as the target site was in the lungs (ifu0101-1).A definitive root cause for the customer complaint could be attributed to user error as the target site was in the lungs and as per ifu101-1 "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope." 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.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC 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: 12663725
• MDR Text Key: 277398180
• Report Number: 3001845648-2021-00729
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)240521(10)C1831796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083330
• 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,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1831796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/21/2021
• Event Location: Hospital
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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: Female
• Patient Weight: 70 KG