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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G34785
Device Problem Break (1069)
Patient Problems Abdominal Pain (1685); No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2018
Event Type  Injury  
Manufacturer Narrative
The 510(k) number; k142688. (b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Information relative to the actual event in (b)(6) hospital (b)(6). It currently contains an extract from the case study. One patient, who was referred to me from another facility, diagnosed with obstructive, jaundice secondary to pancreatic/ periampullary tumor. Patient underwent endoscopic ultra sound fine needle aspiration cytology (eus+fnac) under general, anesthesia (ga) in the month of (b)(6) 2018, which showed a pancreatic head mass lesion (neoplastic?) with dilated common bile duct and pancreatic duct fnac was done using echotip. Background and study aims endoscopic ultrasound guided fine needle aspiration (eus-fna) is widely performed to obtain pathological evidence from several parts of the body. Major complications of eus-fna are bleeding, pancreatitis, and abdominal pain. Needle fracture is a rare complication of eus-fna and only a few relevant reports are available. Here, we report a case of needle fracture during eus-fna using a needle with a side hole. A (b)(6) man underwent eus-fna of the uncinate process of the pancreas to confirm malignancy. A 20-gauge needle with a side hole was used to puncture the mass from the first part of the duodenum. The needle fracture occurred at the side hole during the third passage, and the fragment remained in the pancreas. Fortunately, the patient did not exhibit any symptoms due to the needle fragment. This case indicates that repeated puncture using the same needle with a side hole might increase risk of needle fracture during eusfna. It is important to inform clinicians about the potential risk of needle fracture, particularly given the increasing number of eus-fnas being performed.
 
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Brand NameECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Type of DeviceFCG 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
heather ryan
o halloran road
national technology park
limerick 
061334440
MDR Report Key7855019
MDR Text Key119539401
Report Number3001845648-2018-00415
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002347854
UDI-Public(01)00827002347854(17)201213(10)C1431977
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2020
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberC1431977
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/06/2018
Event Location Hospital
Date Manufacturer Received08/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/07/2018 Patient Sequence Number: 1
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