MAUDE Adverse Event Report: COOK IRELAND LTD; FCG KIT, NEEDLE, BIOPSY

Catalog Number UNKNOWN

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

Patient Problem Inflammation (1932)

Event Date 05/12/2014

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.As exact rpn is unknown then this is the list of potential 510 k #¿s: k160229 or k142688.Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the mild pancreatitis, the following is a list of potential rpn¿s: echo-hd-22-ebus-o ¿ c (k160229) / echo-hd-25-ebus-o ¿ c (k160229) or echo-hd-22-c (k142688) / echo-hd-25-c (k142688).As per 'medical device reporting for manufacturer's (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.

Event Description

Title of literature: core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study - lee et al 2014.Study aims: we prospectively compared the diagnostic accuracy of eus-fnb with standard eus guided fine needle aspiration (eus-fna) in patients with solid pancreatic masses.One case of mild pancreatitis occurred in the fna group, which was managed conservatively with 2 days of hospitalization.This file is created to capture one case of mild pancreatitis.Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the mild pancreatitis, the following is a list of potential rpn¿s: echo-hd-22-ebus-o / echo-hd-25-ebus-o or echo-1-22 / echo-25.As per 'medical device reporting for manufacturer's (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.

Manufacturer Narrative

As exact rpn is unknown then this is the list of potential 510 k #¿s: k160229 or k142688.Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the mild pancreatitis, the following is a list of potential rpn¿s: echo-hd-22-ebus-o ¿ c (k160229) / echo-hd-25-ebus-o ¿ c (k160229) or echo-hd-22-c (k142688) / echo-hd-25-c (k142688).As per 'medical device reporting for manufacturer's (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.Device evaluation: the unknown devices of unknown lot numbers 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 "lee et al 2014".Complaint files (b)(4) were opened as a result of this paper.This file (b)(4) was opened to investigate one case of mild pancreatitis.Documents review including ifu review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution echo devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the echo devices from unknown lot number, a review of the relevant manufacturing records cannot be conducted.As per the instructions for use, ifu0077-4 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, damage to blood vessels, nerve damage, and acute pancreatitis.Those associated with eus needle biopsy include but are not limited to: pain, death, peritonitis, portal vein gas and thrombosis, pneumoperitoneum and tumor seeding of the needle tract.Root cause review: a definitive root cause could not be determined from the available information.As per the ifu and as per medical affairs potential complications include acute pancreatitis.Summary: 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

Title of literature: core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study - lee et al 2014.Study aims: we prospectively compared the diagnostic accuracy of eus-fnb with standard eusguided fine needle aspiration (eus-fna) in patients with solid pancreatic masses.One case of mild pancreatitis occurred in the fna group, which was managed conservatively with 2 days of hospitalization.This file is created to capture one case of mild pancreatitis.Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the mild pancreatitis , the following is a list of potential rpn¿s: echo-hd-22-ebus-o / echo-hd-25-ebus-o or echo-1-22 / echo-25.As per 'medical device reporting for manufacturer's (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.

• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9932670
• MDR Text Key: 196569287
• Report Number: 3001845648-2020-00235
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/12/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization