MAUDE Adverse Event Report: SCANLAN INTERNATIONAL SCANLAN® VASCULAR TUNNELER AND BULLET TIP

Model Number	9009-18
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction

• Brand Name: SCANLAN® VASCULAR TUNNELER AND BULLET TIP
• Common Device Name: VASCULAR TUNNELER
• Manufacturer (Section D): SCANLAN INTERNATIONAL; one scanlan plaza; saint paul MN 55107 1629
• Manufacturer (Section G): SCANLAN INTERNATIONAL, INC.; one scanlan plaza; saint paul MN 55107
• Manufacturer Contact: mark watson ; one scanlan plaza; saint paul, MN 55107 ; 6517285759
• MDR Report Key: 25894209
• Report Number: 2126670-2026-00004
• Device Sequence Number: 15987813
• Product Code: DWS
• UDI-Device Identifier: 00846159000986
• UDI-Public: (01)00846159000986(10)8339902(17)300917
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

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
• Operator of Device: Health Professional
• Device Model Number: 9009-18
• Device Catalogue Number: 9009-18
• Device Lot Number: 8378504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2025
• 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: Required Intervention
• Patient Sex: Unknown