MAUDE Adverse Event Report: SCANLAN TUNNELER SHEATH AND BULLET TIP

Model Number 9009-16

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/21/2017

Event Type  Injury  

Event 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
• Type of Device: BULLET TIP
• Manufacturer (Section D): SCANLAN; st. paul MN 55107
• MDR Report Key: 6843293
• MDR Text Key: 85078113
• Report Number: MW5071953
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00846159000979
• UDI-Public: (01)00846159000979
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 9009-16
• Device Lot Number: 5335701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 92