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

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.

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.There was no lot number provided for this complaint.Therefore, no record review could be completed by the on control supplier.Case details were reviewed.A patient with a history of thrombocytosis was admitted for acute embolic stroke and carotid dissection.The patient underwent a bone marrow biopsy.Procedure was completed without difficulty.Patient had intractable hip pain post discharge.Mri revealed fluid collection involving entirety of the gluteus medius muscle on the left most compatible with posttraumatic intramuscular hematoma.Ifu states the following: loss of sensitivity, pain and hematoma are potential side effects from using the on control bone marrow aspiration and bone marrow biopsy system.No product was returned for evaluation.No angiograms or mri report and images were shared.No orthopedic intervention was done.Ice applied to site.Heparin drip restarted and transitioned to apixaban.It is unknown and unclear if vessel damages could have occurred during biopsy procedure or if any other anatomical factors led to the issue.It is unknown if the needle was set into the bone too shallow or too far causing damages to anatomy or hitting undesired targets.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: ONCONTROL
• Type of Device: ONCONTROL 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 Key: 14956576
• MDR Text Key: 295491103
• Report Number: 2134812-2022-00040
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142377
• Number of Events Reported: 1
• 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 Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9407-VC-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male