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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 7267X
Device Problem Material Frayed (1262)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/16/2022
Event Type  Injury  
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.
 
Event Description
As reported: the physician used a micro puncture kit (mik) for internal jugular (ij) access, the wire got curled up, so she pulled it out and it sheared coming back out of the needle. I was not present during this incident. The radiology technician was there and explained what happened and saved the mik to return for investigation. Additional information received on 23may2022: no part of the guidewire that was sheared was left behind in the vessel.
 
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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 Key14632046
MDR Text Key293553925
Report Number2134812-2022-00034
Device Sequence Number1
Product Code DYB
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 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7267X
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/08/2022 Patient Sequence Number: 1
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