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 06/29/2022

Event Type  malfunction  

Event Description

User advanced the endoscopy to stomach and scan tail of pancreas, then advance the endoscopy along splenic vein to left renal vein, then retracted the endoscopy to cardia (of stomach).User picked the outflow tract of gastric varicose vein.User utilized echo-19 penetrated the vein and attempt to place the proper coil but found out the needle cannot be advanced into needle track.User then retracted the device and changed to another same device to complete the procedure.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.

Manufacturer Narrative

Pma/510(k) #: k210476.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 evaluated on 11-aug-2022: visual inspection: stylet returned separate to device.Distal end of needle examined no issue observed.Needle removed and proximal kink observed below the sheath extender.Functional inspection: sheath extender able to advance and retract with no issue.Needle advance and retract with no issue.Stylet re inserted but would not pass proximal kink below the sheath extender.

Manufacturer Narrative

Pma/510(k) # k210476.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplement report being submitted due to the completion of the investigation on (b)(6) 2022.

Manufacturer Narrative

Pma/510(k) # (b)(4).Device evaluation 1 unit of lot c1888935 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 (b)(6) 2022.Visual inspection - stylet returned separate to device.- distal end of needle examined no issue observed.- needle removed and proximal kink observed below the sheath extender.Functional inspection - sheath extender able to advance and retract with no issue.- needle advance and retract with no issue.- stylet re inserted but would not pass proximal kink 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 c1888935 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 c1888935.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 evidence to suggest that the customer did not follow the instructions for use, as the customer used the device for an endoscopic ultrasound-guided gastrorenal shunt coil placement under tracheal intubation which would be considered off-label use as per ifu0101 "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope." off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.Root cause review a definitive root cause for the customer complaint could be attributed to off-label use as the device was used for endoscopic ultrasound-guided gastrorenal shunt coil placement under tracheal intubation which would be considered off-label use as per ifu0101 "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope." 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.

• 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: 15120524
• MDR Text Key: 304300740
• Report Number: 3001845648-2022-00483
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: C1888935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2022
• Event Location: Hospital
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• 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 Age: 55 YR
• Patient Sex: Male