MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VSI MICRO INTRODUCER KIT-STIFFEN 5 F; INTRODUCER, CATHETER

Catalog Number 7267V

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Distal tip of micropuncture access wire became entrapped in the wall of the left common femoral vein.Fda safety report id # (b)(4).

• Brand Name: VSI MICRO INTRODUCER KIT-STIFFEN 5 F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC
• MDR Report Key: 12711479
• MDR Text Key: 279253455
• Report Number: MW5104998
• Device Sequence Number: 1
• Product Code: DYB
• 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: 10/25/2021

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: 02/12/2024
• Device Catalogue Number: 7267V
• Device Lot Number: 73B2100222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2021
• 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): Other
• Patient Age: 44 YR
• Patient Weight: 111