MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. VSI MICRO-INTRODUCER KITS

Model Number VSI 5 F STIFFEN

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  malfunction  

Event Description

Md inserted needle to get access.Md inserted guide wire.Md inserted sheath through guide wire.When he removed inner sheath, he noticed that the introducer was not intact.He then pulled back the wire and noticed that the remaining introducer was stuck to the wire.All components were successfully retrieved and accounted for.Diagnosis or reason for use: sick sinus syndrome.

• Brand Name: VSI MICRO-INTRODUCER KITS
• Type of Device: VSI MICRO-INTRODUCER KITS
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC. ; 6464 sycamore court north ; minneapolis MN 55369
• MDR Report Key: 7285735
• MDR Text Key: 100765977
• Report Number: MW5075387
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/05/2018

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: 12/04/2020
• Device Model Number: VSI 5 F STIFFEN
• Device Catalogue Number: REF 7267V
• Device Lot Number: 617394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2018
• 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 Age: 87 YR
• Patient Weight: 59