MAUDE Adverse Event Report: SCANLAN INTERNATIONAL SCANLAN VASCULAR TUNNELER

Model Number 9009-18

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 338892098
• Report Number: 2126670-2024-00003
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00846159000986
• UDI-Public: 00846159000986
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 66 KG