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 10/05/2021

Event Type  malfunction  

Event Description

While using the first needle to do a rendezvous procedure [off label] in the biliary duct via stomach access, the physician extended the needle but when trying to retract the needle it would not retract.It felt as if the handle came back but the needle stayed extended.The needle was removed and set aside for return to cook.Please describe the location in the body for the intended target site? biliary duct.Was the device used in a tortuous position? no.Are images of the device or procedure available? no.Was the device damaged in packaging before removal? no.Was the device damaged on removal from packaging? no.Was force required to remove the device? no.What is the endoscope manufacturer and model number that was used? olympus.Was resistance felt while inserting the device through the scope? resistance first needle when pulling back.When was the issue noted? when attempting to retract needle.Was the syringe used during the procedure, after the stylet was removed? no.Was difficulty experienced while retracting the needle? yes.Was it possible to be fully retract before removing the needle from the patient? no.Was gaining access to the targeted site difficult? no.Was the endoscope in a flexed or twisted position at any time during the procedure? no.Was puncture of the targeted site difficult? na.Was the stylet fully in place inside the needle when advancing into the targeted site? na.Was the stylet partially removed when advancing into the target site? na.How many samples were obtained with this needle? zero.Did any section of the device detach inside the patient? no.

Manufacturer Narrative

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

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, proximal needle breakage below sheath extender was observed.

Event Description

This follow-up mdr is being submitted to capture the receipt of answers to the 'patient outcome questions' received on 04-apr-2022 as follows: did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? na.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation 1 unit of lot c1846778 of echo-19 involved in this complaint was returned for evaluation, with its original opened packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation the device involved in the complaint was evaluated in the laboratory on 21 october 2021.- sheath extender able to retract but unable to pass kink below the sheath extender - unable to advance needle handle - removed needle from device and needle break observed below the sheath extender document review including ifu review 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 c1846778 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 c1846778.The notes section of the instructions for use, ifu0101 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 no evidence to suggest that the customer did not follow the instructions for use (ifu0101).Root cause review a definitive root cause for the customer complaint could be attributed to off-label as the device was used for drainage and as per ifu0101 "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope." it is possible that the conditions brought about when using the device other than specified within the ifu may have contributed to the proximal break below the sheath extender leading to the customer being unable to retract the needle.As per medical affairs "this echo-19 was deemed off-label because the needle was used as an access needle rather than sampling a lesion.") 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.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 02-jun-2022.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 12736916
• MDR Text Key: 283787640
• Report Number: 3001845648-2021-00774
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)240705(10)C1846778
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2024
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1846778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 10/07/2021; 10/07/2021; 10/07/2021
• Supplement Dates FDA Received: 11/19/2021; 04/29/2022; 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• 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