MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION CENTURION; GENERAL SURGERY TRAY

Model Number	ART945
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During insertion of the femoral art line the guidewire began to unravel and became stuck in the needle and vessel.Guidewire was withdrawn.Surgeon called to bedside to do a cutdown to retrieve the wire.Incision needed to remove the guidewire from the artery.

• Brand Name: CENTURION
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 301 catrell dr; howell MI 48843
• MDR Report Key: 24616159
• Report Number: 24616159
• Device Sequence Number: 21290442
• Product Code: LRO
• UDI-Device Identifier: 10653160366843
• UDI-Public: (01)10653160366843
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026
• Report Date (Section F): 03/03/2026

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
• Device Model Number: ART945
• Device Catalogue Number: ART945
• Device Lot Number: 2025082590
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/03/2026