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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC ONCONTROL ONCONTROL BONE ACCESS AND BONE BIOPSY

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VASCULAR SOLUTIONS, LLC ONCONTROL ONCONTROL BONE ACCESS AND BONE BIOPSY Back to Search Results
Model Number 9407-VC-006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 03/28/2022
Event Type  Injury  
Manufacturer Narrative
An investigation has been opened and a follow-up report will be submitted after investigation.
 
Event Description
As reported: retroperitoneal hematoma, 75 year old female with a history of hypertension, cad and nhl, in remission, who underwent an outpatient left bone marrow biopsy on (b)(6) 2022 using the power driven needle (oncontrol system). Pt was on aspirin and plavix (last dose 3/26/22). The procedure was completed without difficulty using propofol sedation.
 
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Brand NameONCONTROL
Type of DeviceONCONTROL BONE ACCESS AND BONE BIOPSY
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
mary haufek
6464 sycamore court north
minneapolis, MN 55369
7636564300
MDR Report Key14956482
MDR Text Key295490192
Report Number2134812-2022-00038
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142377
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 06/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9407-VC-006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/08/2022 Patient Sequence Number: 1
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