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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 Problems Extravasation (1842); Hematoma (1884); Muscle Weakness (1967)
Event Date 05/10/2022
Event Type  Injury  
Manufacturer Narrative
An investigation has been opened and a follow-up report will be submitted after investigation.
 
Event Description
As reported: 30 year old male who presented to fh with headache and diffuse pain over entire body. Had shortness of breath, abdominal swelling and lower extremity swelling for 3-4 months. History of substance abuse. A cbc identified a high wbc with 75% blasts. He was transferred to ro for possible leukapheresis. A bone marrow biopsy was performed on (b)(6) 2022, which was positive for cml in blast crisis. Patient was started on nilotinib. On 5/23/22 he noticed swelling and tenderness at bone marrow biopsy site, with thigh pain. A cta of aorta with run off was performed on (b)(6) 2022 and was "negative for active extravasation, occlusion or dissection. No active extravasation within the region of the known bone marrow biopsy involving the left iliac bone. Periosteal reaction left femoral diaphysis. Given reported cellulitis after discussion with ordering physician, osteomyelitis is a diagnostic consideration". I&d of bone marrow biopsy site was performed with minimal purulent fluid drained. Empiric vanc/zosyn started due to immunocompromised state. A cta of the chest/abdomen/pelvis was performed on (b)(6) 2022 and did reveal a left retroperitoneal hematoma confined to the psoas muscle measuring up to 6. 8cm, which exerts mass effect on the adjacent kidney and is grossly stable compared to cta runoff from on (b)(6) 2022. Bleeding from bone marrow site noted on (b)(6) 2022. Further surgical intervention not indicated. Patient is complaining of left lower extremity weakness which is likely due to femoral plexopathy from the retroperitoneal bleed. Neurology consulted and recommended outpatient mri and to continue monitoring lle weakness. If no improvement in 3 weeks may obtain emg. Patient currently still admitted.
 
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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 Key14956637
MDR Text Key295491644
Report Number2134812-2022-00041
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 Received06/17/2022
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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