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

Catalog Number UNKNOWN

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pancreatitis (4481)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: k160229/k142688.

Event Description

Kovacevic et al 2020 - eus tissue acquisition: from a to b (review article).This review article does not provide any specific information in relation to patients, procedures or devices use.Overall adverse effects were referenced as below for fnb / procore needles: eus ta is an established and safe procedure with an overall risk of adverse events as low as 0.29%.Hemorrhage (0.15%¿3.7%) - observed hemorrhage is in most cases self limiting, and eus ta can be safely performed even in patients treated with aspirin and nonsteroidal anti inflammatory drugs.However, p2y12 receptor antagonists and oral anticoagulants should be discontinued prior to eus ta in order to minimize the risk of hemorrhage.Acute pancreatitis (0.29%¿2.0%).Infection (0.4%¿3.9%) - risk of infection is considered generally low when performing eus ta of solid lesions, even in transrectal and/or transcolonic approach, and current guidelines do not recommend routine prophylactic antibiotic treatment when biopsy of solid lesions is performed.In case of cystic lesions, however, the risk of infection is higher, and administration of prophylactic antibiotics is recommended.

Manufacturer Narrative

Pma/510(k) #: k160229/k142688 device evaluation the echo tip procore device of unknown rpn and unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.The percentages for haemorrhage, acute pancreatitis and infection listed in the paper are compared to those in the cer for risk assessment.This approach is being taken as the paper does not specify the number of patients involved in the study and the number of patients that experienced each effect.Lab evaluation n/a image review n/a d0cument review prior to distribution, all echo tip procore 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 number is unknown a review of manufacturing records could not be performed.There is no evidence to suggest from the literature article that the relevant users did not follow the instructions for use (ifu0077).Root cause review a definitive root cause could not be determined from the available information.A possible root could be attributed to the procedure.According to the medical advisor, haemorrhage, acute pancreatitis, and infection are common complications during eus-fna procedure, which are associated with eus needle usage and are related to the procedure.Patients undergoing eus-fna for pancreatic lesions are at particular risk of post-procedure pancreatitis as the procedure involves passage of the needle through the pancreatic issue.Haemorrhage is inherent to the puncturing procedure; the infection is likely related to cystic lesions when comparing with solid lesions.Therefore, the echo needle is associated with these adverse events, but might not necessarily contributed to the occurrences.However there was no evidence of a failure reported associated with the actual devices.As per the ifu potential complications include haemorrhage, acute pancreatitis, and infection summary complaint is confirmed based on customer testimony.According to the information reported, the patients required intervention/additional procedures to prevent permanent impairment/damage.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the (b)(6) 2022.

• 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
• 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: 13024303
• MDR Text Key: 283976719
• Report Number: 3001845648-2021-00875
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention