MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

Catalog Number ECHO-HD-22-C

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

Patient Problem Inflammation (1932)

Event Date 03/20/2012

Event Type  Injury  

Manufacturer Narrative

Common name: fcg kit, needle, biopsy.Product code: fcg.

Event Description

As reported to customer relations via literature article: title of literature review: 'randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for eus-guided sampling of solid pancreatic mass lesions' bang et al 2012.'only 2 patients in the entire cohort had complications: 1 patient (3.6%) in the fna group had postprocedural abdominal pain that was managed conservatively on an outpatient basis, and 1 patient (3.6%) in the fnb cohort developed mild acute pancreatitis that required hospitalization for 2 days.' this file is created to capture 1 patient (3.6%) in the fnb cohort developed mild acute pancreatitis that required hospitalization for 2 days.' 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 acute pancreatitis , the following is a list of potential rpn¿s: 22 g fnb needle (echotip pro core) could include: itf052-en ebus needles: echo-hd-22-ebus-o - c or itf039-an aspiration needles: echo-hd-22-c.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

D2) fcg kit, needle, biopsy.

Event Description

Please note this report will update the rpn to echo-hd-22-c.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9932632
• MDR Text Key: 193020686
• Report Number: 3005580113-2020-00349
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 05/28/2020,06/01/2020

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: ECHO-HD-22-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2020
• Distributor Facility Aware Date: 05/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization