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U.S. Department of Health and Human Services

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

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VASCULAR SOLUTIONS, LLC MICRO-INTRODUCER KIT CATHETER Back to Search Results
Model Number 7264V
Device Problem Material Frayed (1262)
Patient Problem Insufficient Information (4580)
Event Date 07/27/2022
Event Type  malfunction  
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Brand NameMICRO-INTRODUCER KIT
Type of DeviceCATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
Manufacturer Contact
angela meister
6464 sycamore court north
minneapolis, MN 55369
7636564253
MDR Report Key15263248
Report Number2134812-2022-00050
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10841156107109
UDI-Public10841156107109
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180913
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7264V
Device Catalogue Number7264V
Device Lot Number73C2200198
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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