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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. GREBSET MICRO-INTRODUCER KIT
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VASCULAR SOLUTIONS, INC. GREBSET MICRO-INTRODUCER KIT Back to Search Results
Model Number 7951
Device Problems Detachment Of Device Component (1104); Component Falling (1105); Positioning Problem (3009)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/13/2015
Event Type  malfunction  
Event Description
A grebset was used during a patient procedure.During the procedure, the guidewire provided with the grebset encountered resistance.The tip of the guidewire separated and was left in the patient.There was no escalation of care due to the event.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
GREBSET MICRO-INTRODUCER KIT
Type of Device
MICRO-INTRODUCER KIT
Manufacturer (Section D)
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
maple grove MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
maple grove MN 55369
Manufacturer Contact
renee michael
6464 sycamore court north
maple grove, MN 55369
7636564366
MDR Report Key4528913
MDR Text Key5505041
Report Number2134812-2015-00005
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/30/2016
Device Model Number7951
Device Lot Number573199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/20/2015
Initial Date FDA Received02/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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