MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ARTERIAL CATHETER MINI-KIT 20GA X 6"; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	498101
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Following cardiac surgery, a patient presented to the icu with the named product placed in her left radial artery, which had been instilled 4 hours earlier.Lab personnel accessed the line to draw post op labs, then noted to the room nurse that there was some bleeding from the line dressing.The room nurse investigated and attempted to manipulate the line to stop further bleeding.When this did not work, the nurse attempted to remove the dressing to visualize the issue.When the dressing was removed, the hub of the arterial line came away from the insertion site, but the catheter remained in the patient's radial artery.The icu providers were immediately notified of the issue.The catheter was not visible, but it could be palpated under the skin and visualized with ultrasound.The patient had to have an additional procedure with hand surgery to remove the catheter.We do still have the device.

• Brand Name: ARTERIAL CATHETER MINI-KIT 20GA X 6"
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 16277023
• Report Number: 16277023
• Device Sequence Number: 6474926
• Product Code: GDY
• UDI-Device Identifier: 00886333215546
• UDI-Public: 00886333215546
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2023
• Report Date (Section F): 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 498101
• Device Catalogue Number: 498101
• Device Lot Number: 11448906
• 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: 02/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/23/2023