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 Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Kim 2019 ¿a rare fatal bile peritonitis after malposition of endoscopic ultrasound-guided 5-fr naso-gallbladder drainage¿.An (b)(6) year-old female patient was admitted to our hospital presenting with yellow skin color and anorexia with abdominal pain for two weeks.Physical examination revealed right upper quadrant tenderness and equivocal murphy¿s sign without other remarkable findings.Her initial vital signs were stable.The laboratory test results were as follows: white blood cell count, 4,900/mm3; serum hemoglobin, 10.7 g/dl; aspartate transaminase, 205 u/l; alanine transaminase, 254 u/l; alkaline phosphatase, 1,259 u/l; total bilirubin, 8.9 mg/dl; blood urea nitrogen/creatinine, 8/0.7 mg/dl; amylase, 56 u/l; and ca19-9, 22 u/ml.An abdominal computed tomography (ct) scan showed segmental enhanced distal bile duct stenosis with upstream bile duct dilation and gb distension suggestive of distal common bile duct malignancy (fig.1).The endoscopic retrograde cholangiogram showed similar bile duct findings.A biopsy with brush cytology (boston scientific, natick, ma, usa) was performed for the distal bile duct lesion.Two 7-fr pigtail plastic stents (zimmon biliary stent; cook endoscopy, bloomington, in, usa) were inserted for biliary decompression.An eus showed a distended gb with wall thickening consistent with acute cholecystitis.Eus-guided gb drainage was performed after puncture of the gb with a 19-gauge needle.(echotip-19; cook endoscopy, winston-salem, nc, usa).The above does not define what rpn the echotip-19 is specifically.But if they could have used and echo-19, this file will capture the potential off label use of this.As per the ifu for echo-19, the intended use is to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope as per the lit paper ¿eus-guided gb drainage was performed after puncture of the gb with a 19-gauge needle¿.This file will capture 1 case of off label use with echo-19 for access.

Event Description

The investigation was concluded on the 21-dec-2020, this supplement report is being submitted to include the investigation conclusions within section h.

Manufacturer Narrative

Device evaluation: the echo-19 device of unknown lot number involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article to capture off-label use with echo-19 for access.Additional complaint files mdr ref # 3001845648-2020-00976 and 3001845648-2020-00978 were opened as a result of this paper.As per article ¿eus-guided gb drainage was performed after puncture of the gb with a 19-gauge needle¿.As the echo-19 device is from unknown lot number, a review of the relevant manufacturing records cannot be conducted.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.The notes section of the instructions for use, ifu0101-1, which accompanies this device instructs the user "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 echo-19 was used to gain access.As per clinical input "if it was echo-19, off-label." a definitive root cause could be determined from the available information.From the journal article it is known that the user used the device off-label, as the echo-19 was used to access, this would be off-label use.Complaint is confirmed based on customer testimony.Patient death was reported in this case study however the use of the echo-19 is not a contributing factor in the death.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
• MDR Report Key: 11047245
• MDR Text Key: 252612999
• Report Number: 3001845648-2020-00977
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 05/24/2019
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR