MAUDE Adverse Event Report: SCANLAN INTERNATIONAL, INC. SCANLAN® SINGLE-USE ELLIPTICAL AORTA/VEIN PUNCH

Model Number	1001-610
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for further analysis.Review of the design, manufacturing batch record, and technical documentation found no non-conformities.Unable to draw a conclusion from the information available.
Event or Problem Description
"during a live donor kidney transplant, the aortic punch did not cut properly and tore the artery".As reported.A young patient underwent a kidney transplant from a living donor.During the surgery, an arteriotomy was performed, and the scanlan aortic punch was used.However, the device failed to function properly and became jammed, causing significant damage to the external iliac artery.As a result, resection of the damaged arterial segment was required, followed by the placement of a ptfe vascular graft and anastomosis of the kidney graft onto this prosthetic graft.Despite these measures, adequate blood flow could not be established, and a nephrectomy of the transplanted kidney was necessary.

• Brand Name: SCANLAN® SINGLE-USE ELLIPTICAL AORTA/VEIN PUNCH
• Common Device Name: VEIN PUNCH
• Manufacturer (Section D): SCANLAN INTERNATIONAL, INC.; one scanlan plaza; saint paul 55107 1608
• Manufacturer (Section G): SCANLAN INTERNATIONAL, INC.; one scanlan plaza; saint paul 55107 1608
• Manufacturer Contact: mark watson ; one scanlan plaza; saint paul 55107-1608 ; 6517285759
• MDR Report Key: 22204556
• Report Number: 2126670-2025-00001
• Device Sequence Number: 20872594
• Product Code: KDC
• UDI-Device Identifier: 00846159000924
• UDI-Public: 00846159000924
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1001-610
• Device Catalogue Number: 1001-610
• Device Lot Number: 8023401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 22 YR
• Patient Sex: Female