MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-19-C

Device Problems Off-Label Use (1494); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.[cailol f drainage of the right liver under eus guidance.Pdf].

Event Description

Event reported from literature.Paper title: drainage of the right liver under eus guidance: a bridge technique allowing drainage of the right liver through the left liver into the stomach or jejunum.Country of origin: (b)(6).Patient conditions: patients with inaccessible papilla due to altered anatomy or duodenal invasion and drainage under eus guidance and bridge technique without previous biliary drainage were included in the study.Brief description: both ultra 19-a and ultra 19 were off label use.(related to (b)(4)).Event description: twelve patients were included in the study.Inclusion criteria were malignant hilar stenosis of the bile duct, inaccessible papilla due to duodenal stenosis or altered anatomy, and an attempt of the bridge technique.The procedure was performed with patients intubated and sedated and in the supine position.The liver segment ii or iii was punctured with a 19 g access needle ((echotip ultra 19- a, cook medical, usa) or a standard 19 g needle (echotip ultra 19, cook medical) with a therapeutic echoendoscope ((b)(4) [pentax, (b)(6)]).Both ultra 19-a and ultra 19 were off label use.

Manufacturer Narrative

Pma/510(k) #k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Event reported from literature.Paper title: drainage of the right liver under eus guidance: a bridge technique allowing drainage of the right liver through the left liver into the stomach or jejunum country of origin: france patient conditions: patients with inaccessible papilla due to altered anatomy or duodenal invasion and drainage under eus guidance and bridge technique without previous biliary drainage were included in the study.Brief description: both ultra 19-a and ultra 19 were off label use.(related to 286491) event description: twelve patients were included in the study.Inclusion criteria were malignant hilar stenosis of the bile duct, inaccessible papilla due to duodenal stenosis or altered anatomy, and an attempt of the bridge technique.The procedure was performed with patients intubated and sedated and in the supine position.The liver segment ii or iii was punctured with a 19 g access needle ((echotip ultra 19- a, cook medical, usa) or a standard 19 g needle (echotip ultra 19, cook medical) with a therapeutic echoendoscope (eg38utk [pentax, tokyo, japan]).Both ultra 19-a and ultra 19 were off label use.

Manufacturer Narrative

Pma/510(k) #k142688.Device evaluation.The echo-hd-19-c 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 article to address off label use of echo-hd-19-c device.Lab evaluation n/a-the device did not return.Document review prior to distribution, all echo-hd-19-c 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.There is evidence to suggest that the customer did not follow the instructions for use (ifu0077).¿this device is used with ultrasound endoscope for fine needle biopsy, (fnb), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.¿ there is no indication for use in the liver.Root cause review a definitive root cause could be attributed to off label use.Summary the complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Event reported from literature.Paper title: drainage of the right liver under eus guidance: a bridge technique allowing drainage of the right liver through the left liver into the stomach or jejunum.Country of origin: france.Patient conditions: patients with inaccessible papilla due to altered anatomy or duodenal invasion and drainage under eus guidance and bridge technique without previous biliary drainage were included in the study.Brief description: both ultra 19-a and ultra 19 were off label use.Event description: twelve patients were included in the study.Inclusion criteria were malignant hilar stenosis of the bile duct, inaccessible papilla due to duodenal stenosis or altered anatomy, and an attempt of the bridge technique.The procedure was performed with patients intubated and sedated and in the supine position.The liver segment ii or iii was punctured with a 19 g access needle ((echotip ultra 19- a, cook medical, usa) or a standard 19 g needle (echotip ultra 19, cook medical) with a therapeutic echoendoscope (eg38utk [pentax, tokyo, japan]).Both ultra 19-a and ultra 19 were off label use.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9443894
• MDR Text Key: 220064719
• Report Number: 3001845648-2019-00702
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2020

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-HD-19-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 11/12/2019; 11/12/2019
• Supplement Dates FDA Received: 01/07/2020; 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1