MAUDE Adverse Event Report: SCANLAN TUNNELER SHEATH AND BULLET TIP

Catalog Number 9009-16

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 03/28/2016

Event Type  Injury  

Event Description

Surgeon was using a vein tunneler sleeve and the tip came off in pt during procedure.(left femoral popliteal bypass with ptfe graft.) tip removed under ultrasound with no injury noted.

• Brand Name: TUNNELER SHEATH AND BULLET TIP
• Type of Device: TUNNELER
• Manufacturer (Section D): SCANLAN; st paul MN 55107
• MDR Report Key: 5578542
• MDR Text Key: 42756063
• Report Number: MW5061683
• Device Sequence Number: 1
• Product Code: DWS
• 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: 04/12/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2020
• Device Catalogue Number: 9009-16
• Device Lot Number: 5533901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2016
• 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: 57 YR