MAUDE Adverse Event Report: SCANLAN INTERNATIONAL, INC. 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	Hematoma (1884)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was inspected.The bullet tip was removed and then reassembled to the sheath.It fit into the sheath without falling out, but it was a loose fit.This could be attributed to already being assembled, disassembled, and reassembled.Assembling and disassembling the bullet tip from the sheath can cause the sheath to widen, therefore loosening the interference fit with the bullet tip.Review of the design, manufacturing batch records, and technical documentation found no non-conformities.Inspection of product of another production lot found the tunneler sheaths and bullet tips meet specifications and perform as intended.The ifu cautions users that care must be taken to ensure the bullet tip does not become dislodged during the tunneling procedure.No evidence of product non-conformity.
Event or Problem Description
Email received reported: 9009-18 became faulty during a case; stating bullet tip had a loose fit and became disconnected, and the surgeon had to fish it out of the patient.

• Brand Name: SCANLAN VASCULAR TUNNELER AND BULLET TIP
• Common Device Name: VASCULAR TUNNELER
• Manufacturer (Section D): SCANLAN INTERNATIONAL, INC.; one scanlan plaza; saint paul 55107
• 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: 25523613
• Report Number: 2126670-2026-00003
• Device Sequence Number: 21489663
• Product Code: DWS
• UDI-Device Identifier: 00846159000986
• UDI-Public: (01)00846159000986(10)8339902(17)300917
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 9009-18
• Device Catalogue Number: 9009-18
• Device Lot Number: 8339902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 85 KG