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

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).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.

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.

• 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 Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6724457
• MDR Text Key: 80410354
• Report Number: 3001845648-2017-00289
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)190927(10)C1277838
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G34785
• Device Catalogue Number: ECHO-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 Date: 07/19/2017
• Event Location: Hospital
• Date Manufacturer Received: 08/04/2017
• Date Device Manufactured: 09/27/2016
• 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): Hospitalization