MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP INSIGHT; ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE

Model Number	G46560
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Malfunction while setting up for procedure, unable to flush heparin through the needle, unable to use it.

• Brand Name: ECHOTIP INSIGHT
• Common Device Name: ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; 750 daniels way; bloomington IN 47404
• MDR Report Key: 18484251
• Report Number: 18484251
• Device Sequence Number: 2723089
• Product Code: QIJ
• UDI-Device Identifier: 00827002465602
• UDI-Public: (01)00827002465602(17)230930(10)C2068449
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2023
• Report Date (Section F): 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G46560
• Device Catalogue Number: ECHO-PPG
• Device Lot Number: C2068449
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 08/17/2023