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

Catalog Number ECHO-1-22

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pancreatitis (4481)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Bor et al 2019 ¿prospective comparison of slow-pull and standard suction techniques of endoscopic ultrasound-guided fine needle aspiration in the diagnosis of solid pancreatic cancer.¿ 92 patients were enrolled who underwent eus-fna sampling due to suspected pancreatic cancer.92 eus-fna sampling of 89 patients were involved between january 2014 and june 2016.Linear echoendoscope (olympus gf-uct 140; olympus gf-uct 160; olympus optical, (b)(4)) and 22g fna needles (echotip ultra; cook (b)(4)., (b)(4); ez shot 2, olympus optical, (b)(4)) were applied for the sampling.After the determination of the optimal puncture site, the needle was inserted under continuous real-time ultrasound guidance to the target lesion and approximately 10 to 15 back-and-forth movements were done in a fanning manner.2¿2 punctures using sp and ss technique were proposed to be carried out with the same needle from the same lesion, but reduction or increase of the punctures¿ number was allowed if the examiner considered it necessary based on the quality of the obtained specimen.In case of sp, suction force is generated by the slow pull out of stylet during the back-and-forth movements of needle.In case of ss technique, 5ml syringe was attached to the hub of the needle after quick removal of the stylet to create greater suction force compared to sp.There was no significant difference between the use of cook medical and olympus ez shot 2 needles (47 vs.55 cases).A (b)(6)-year old man developed mild, postprocedural acute pancreatitis, which recovered during 4-days long total parenteral nutrition.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.Initial report details: bor et al 2019 ¿prospective comparison of slow-pull and standard suction techniques of endoscopic ultrasound-guided fine needle aspiration in the diagnosis of solid pancreatic cancer¿ 92 patients were enrolled who underwent eus-fna sampling due to suspected pancreatic cancer.92 eus-fna sampling of 89 patients were involved between (b)(6) 2014 and (b)(6) 2016 linear echoendoscope (olympus gf-uct 140; olympus gf-uct 160; olympus optical, tokyo,japan) and 22g fna needles (echotip ultra; cook ireland ltd., limerick, ireland; ez shot 2, olympus optical, tokyo, japan) were applied for the sampling.After the determination of the optimal puncture site, the needle was inserted under continuous real-time ultrasound guidance to the target lesion and approximately 10 to 15 back-and-forth movements were done in a fanning manner.2¿2 punctures using sp and ss technique were proposed to be carried out with the same needle from the same lesion, but reduction or increase of the punctures¿ number was allowed if the examiner considered it necessary based on the quality of the obtained specimen.In case of sp, suction force is generated by the slow pull out of stylet during the back-and-forth movements of needle.In case of ss technique, 5ml syringe was attached to the hub of the needle after quick removal of the stylet to create greater suction force compared to sp.There was no significant difference between the use of cook medical and olympus ez shot 2 needles (47 vs.55 cases).A 66-year old man developed mild, postprocedural acute pancreatitis, which recovered during 4-days long total parenteral nutrition.

Manufacturer Narrative

The echo-1-22 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article.Reference "bor2019¿.Prior to distribution, all echo-1-22 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.As per the instructions for use, which informs the user about the potential complications "those associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest" there is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.However there was no evidence of a failure reported associated with the actual device.As per the medical affairs ¿pancreatitis could be caused by many factors including infection.So the infection would cover pancreatitis in the potential complications for now.The ifu will be updated including pancreatitis and other more specific complications¿.Complaint is confirmed based on customer testimony.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11548707
• MDR Text Key: 256696199
• Report Number: 3001845648-2021-00232
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-1-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2019
• Event Location: Hospital
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR