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 Type  malfunction  

Manufacturer Narrative

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

Event Description

Negative feedback received from customer as follows: "when doing eus guided rfa, one doctor says it is ok to use our 19 gauge with rfa at pancreatic body, but when comes to the head, our 19 gauge can¿t let through the rfa, while the boston 19 gauge flex can do.Do we have some complains from other regions? another doctor says the reason our 19 cannot be bent to much is because of the slim portion of the sheath tip is fragile to be linked.¿ no adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Device evaluation.The echo-19 devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.Additional pr was opened to capture the negative feedback of the complaint device 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.As the lot numbers are unknown a review of manufacturing records could not be performed.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".Also, ¿intended use: this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is evidence to suggest that the customer did not follow the instructions for use, the user used the device for eus guided rfa which is not permitted as per ifu0101.A definitive root cause for the customer complaint could be attributed to off-label as the user used the device for eus guided rfa which is not permitted as per ifu101 "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope." as per medical advisor ¿trying to let echo device through the rfa concurrently would be off-label use,¿ complaint is confirmed based on customer testimony.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 13-apr-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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12546173
• MDR Text Key: 273781675
• Report Number: 3001845648-2021-00704
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• 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
• Report Date: 04/13/2022

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 Catalogue Number: ECHO-19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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