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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  
Event Description
As reported: 51 year old male with a history of thrombocytosis since 2006. Admitted with acute embolic stroke and carotid dissection ((b)(6) 2022) and started on a heparin drip and hydrea. A left bone marrow biopsy was performed on (b)(6) 2022, using the power driven needle (oncontrol system) without difficulty. Patient tolerated the procedure well. He was discharged on (b)(6) 2022. After discharge he called pcp due to intractable hip pain. Mri of left hip revealed a fluid collection involving nearly the entirety of the gluteus medius muscle on the left most compatible with posttraumatic intramuscular hematoma. No orthopedic intervention required. Pain control and ice to site. Heparin drip restarted and transitioned to eliquis. He was discharged home on (b)(6) 2022. Bone marrow biopsy was consistent with essential thrombocythemia.
 
Manufacturer Narrative
An investigation has been opened and a follow-up report will be submitted after investigation.
 
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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 Key14956576
MDR Text Key295491103
Report Number2134812-2022-00040
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 06/17/2022
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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