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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 06/21/2017
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) # k142688. (b)(4). Exemption number: e2016031. Information pertaining to section g. 1 as follows: importer site contact and address: ed sutkowski cook medical incorporated (cmi) (b)(4). Importer site establishment registration number: (b)(4). The device involved in this complaint has not been returned for evaluation. With the information provided, a document based investigation was carried out. Additional information was received 4th august:" finally i received some information from the customer:the patient outcome is, that he recovered from the pancreatitis. Yes there had been an antibiotic treatment of the pancreatitis the patient was scheduled for a surgery which had been postponed because of the pancreatitis the patient stayed in the hospital until the pancreatitis was gone, then he received the surgery. A more detailed description is hard to give, he was punctured with the procore 20 after this treatment he showed the typical signs of a pancreatitis: high inflammation signs in the blood samples, abdominal pain which radiated to the back and fever. " the customer complaint is considered confirmed based on the customer testimony. As the echo device was not returned for evaluation and no specific device malfunction was noted during the procedure it is not possible to determine the root cause of this complaint however it is most likely procedure and/or patient condition related. As per the instructions for use, that accompanies this device, potential complications with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, damage to blood vessels, nerve damage and acute pancreatitis. Those associated with eus needle biopsy include but are not limited to: pain, death, peritonitis, portal vein gas and thrombosis, pneumoperitoneum and tumor seedling of the needle tract. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
This follow up is being submitted as additional information was received. Patient developed after pancreas puncture pancreatitis. Product wont return. Customer disposed of it. "as per complaint form": pancreatitis after the puncture.
 
Manufacturer Narrative
Pma/510(k) # k142688. (b)(4). The device involved in this complaint has not been returned for evaluation. With the information provided, a document based investigation was carried out. The customer complaint is considered confirmed based on the customer testimony. As the echo device was not returned for evaluation and no specific device malfunction was noted during the procedure it is not possible to determine the root cause of this complaint however it is most likely procedure and/or patient condition related. As per the instructions for use potential complications with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, damage to blood vessels, nerve damage and acute pancreatitis. Those associated with eus needle biopsy include but are not limited to: pain, death, peritonitis, portal vein gas and thrombosis, pneumoperitoneum and tumor seedling of the needle tract. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Patient developed after pancreas puncture pancreatitis. Product wont return. Customer disposed of it. "as per complaint form": pancreatitis after the puncture.
 
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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 Contact
michael galvin
o halloran road
national technology park
limerick 
061334440
MDR Report Key6724457
MDR Text Key247104542
Report Number3001845648-2017-00289
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/19/2017
Event Location Hospital
Date Manufacturer Received08/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/27/2016
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: 07/19/2017 Patient Sequence Number: 1
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