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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 7267V
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
As reported: wire embedded in tissue or plaque. Additional information from medwatch (mw5106388) was received on 01feb2022 - tip of introducer broke off during insertion and became embedded in wall of left femoral artery. Fda safety report id# (b)(4).
 
Manufacturer Narrative
An investigation has been opened to review device history record and risk documentation. A follow-up report will be submitted upon completion of the investigation.
 
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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 Key13604342
MDR Text Key290267104
Report Number2134812-2022-00023
Device Sequence Number1
Product Code DYB
UDI-Device Identifier20841156107076
UDI-Public20841156107076
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 Other,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7267V
Device Lot Number73B2100222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2022 Patient Sequence Number: 1
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