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.

• 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
• 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

• 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

• 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 Sex: No Answer Provided
• Patient Weight: KG
• Patient Outcome(s): Required Intervention