MAUDE Adverse Event Report: SCANLAN INTERNATIONAL, INC. SCANLAN VASCULAR TUNNELING SYSTEM

Model Number 9009-18

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Scanlan international, inc.Has made numerous attempts to obtain further information.No additional information is available.

Event Description

During a vascular tunneling procedure, the bullet tip of the tunneling sheath came off and was almost lost in the patient.The surgeon retrieved the bullet tip with the tunneling instrument being used in the procedure.No impact to the patient.Device discarded.As reported.

• Brand Name: SCANLAN VASCULAR TUNNELING SYSTEM
• Manufacturer (Section D): SCANLAN INTERNATIONAL, INC.; st paul MN
• Manufacturer Contact: mark watson ; one scanlan plaza; st paul, MN 55107
• MDR Report Key: 5117859
• MDR Text Key: 27461205
• Report Number: 2126670-2015-00002
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Report Date: 09/17/2015

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 Model Number: 9009-18
• Device Catalogue Number: 9009-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other