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

Model Number	9408-VC-006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been opened and a follow-up report will be submitted after investigation.
Event or Problem Description
As reported: bone marrow biopsy needle broke inside the patient and couldn't be retrieved using the driver.Additional information on 09may2022 - cannula (broke inside the patient) only.Physician tried to remove cannula with sample and could not remove it.Patient was taken by ambulance to a hospital for surgical removal.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The supplier for oncontrol needles was notified of the complaint.A device history record review was completed by the supplier and no nonconformances were noted.Case details were reviewed.A patient underwent a bone lesion biopsy (blb) procedure in the t11 anatomical site.A bone marrow biopsy kit was used.The needle broke inside the patient and could not be retrieved using the driver.No unit was returned for evaluation.It is unknown what damages could have occurred on the needle.No pictures were shared by the account.Additional information was requested from the account.A response was received.Only the cannula broke.Physician tried to remove the cannula with sample but was unsuccessful.Approximately 10 cm of the cannula was left behind.The procedure was aborted, and the patient was sent to a hospital for a surgical removal.The ifu was reviewed, and the following was noted: the arrow® oncontrol® bone marrow aspiration system is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients.The arrow® oncontrol® bone marrow biopsy system is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients.Per intake information, the bone marrow biopsy (bmb) unit was used in an unintended location i.E., t11 which is a thorax vertebral site.It is unknown if excessive force was applied during the procedure.Based on the information, the most likely root cause of the issue is user error due to the use of a bmb product for a blb procedure in an unintended location.

• Brand Name: ONCONTROL
• Common Device Name: ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM
• 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: 14437375
• Report Number: 2134812-2022-00029
• Device Sequence Number: 5151285
• Product Code: FCG
• UDI-Device Identifier: 10841156108670
• UDI-Public: 10841156108670
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: 9408-VC-006
• Device Catalogue Number: 9408-VC-006
• Device Lot Number: 61704034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 103 KG