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U.S. Department of Health and Human Services

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

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VASCULAR SOLUTIONS LLC VSI MICRO INTRODUCER KIT INTRODUCER, CATHETER Back to Search Results
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).
 
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Brand NameVSI MICRO INTRODUCER KIT
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS LLC
minneapolis MN 55369
MDR Report Key13196235
MDR Text Key283506495
Report NumberMW5106518
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7210V 5F
Device Lot Number73E2100496
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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