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

Catalog Number ECHO-HD-22-C

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Fcg kit, needle, biopsy - [15 abdelfatah - the diagnostic and cellularity yield of reverse.Pdf].

Event Description

According to the article: "title 'the diagnostic and cellularity yield of reverse bevel versus forktip fine needle biopsy - abdelfatah et al 2018.Consecutive patients with upper gastrointestinal lesions undergoing eus-fnb (endoscopic ultrasound fine needle biopsy) using 22 gauge procoretm (reverse bevel) or sharkcoretm (fork-tip) needles were included in the study.Eus-fnb was performed on all solid lesions (masses and lymph nodes) using the reverse bevel needle in consecutive patients.The study included 301 patients with a mean age of 67.2612.6.Of the total population, 157 patients were female, and 144 were males.Out of the 301 patients, 139 patients were in the reverse bevel needle group and 162 in the fork-tip needle group.One patient in the reverse bevel needle group developed severe bleeding requiring a blood transfusion.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10198201
• MDR Text Key: 198694006
• Report Number: 3005580113-2020-00376
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2020
• 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
• Patient Age: 67 YR