MAUDE Adverse Event Report: SCANLAN INTERNATIONAL SCANLAN VASCULAR TUNNELER

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	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"the cap became dislodged during position adjustment.Under fluro the cap was found.The incision was extended.The fascia and abductor magnus was devided to retrieve the cap, deep in the femur.One arterial and venous branch pair of the distal profunda femorial artery avulsed and required repair.This added at least one hour of surgery time." as reported.
Additional Manufacturer Narrative
The tunneler sheath and bullet tip in question was not returned for further analysis, and no further information was made available by the reporting institution.Review of the design, manufacturing batch record, and technical documentation show that there were no non-conformities.Inspections of product from the same lot indicate that the tunneler sheaths and bullet tips measured within spec and performed as intended.Unable to draw a conclusion from the available information.

• Brand Name: SCANLAN VASCULAR TUNNELER
• Common Device Name: VASCULAR TUNNELER
• Manufacturer (Section D): SCANLAN INTERNATIONAL; one scanlan plaza; saint paul MN 55107 1629
• Manufacturer (Section G): SCANLAN INTERNATIONAL; one scanlan plaza; saint paul MN 55107 1629
• Manufacturer Contact: mark watson ; one scanlan plaza; saint paul, MN 55107-1629 ; 6517285759
• MDR Report Key: 18998976
• Report Number: 2126670-2024-00003
• Device Sequence Number: 20890936
• Product Code: DWS
• UDI-Device Identifier: 00846159000986
• UDI-Public: 00846159000986
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/28/2024

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: 6625601
• 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: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2022
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 66 KG