MAUDE Adverse Event Report: SCANLAN TUNNELER SHEATH AND BULLET TIP

Model Number	9009-16
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
While passing the tunneler during an axillo-bifemoral bypass the bullet tip separated from the tunneler device and remained in the patient.X-ray was performed to locate the bullet tip and the tip was retrieved.

• Brand Name: TUNNELER SHEATH AND BULLET TIP
• Common Device Name: BULLET TIP
• Manufacturer (Section D): SCANLAN; st. paul MN 55107
• MDR Report Key: 6843293
• Report Number: MW5071953
• Device Sequence Number: 18848454
• Product Code: DWS
• UDI-Device Identifier: 00846159000979
• UDI-Public: (01)00846159000979
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

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 Expiration Date: 10/31/2018
• Device Model Number: 9009-16
• Device Lot Number: 5335701
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 92