MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VSI MICRO INTRODUCER KIT; INTRODUCER, CATHETER

Catalog Number 7210V 5F

Device Problems Unraveled Material (1664); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

While inserting micro puncture needle and wire, wire would not advance.Attempt to pull back wire through needle but appeared to be stuck, attempt again and wire removed but became unraveled with small portion remaining in pt.Fda safety report id# (b)(4).

• Brand Name: VSI MICRO INTRODUCER KIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN 55369
• MDR Report Key: 13196235
• MDR Text Key: 283506495
• Report Number: MW5106518
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Catalogue Number: 7210V 5F
• Device Lot Number: 73E2100496
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White