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

Model Number 9408-VC-006

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

An investigation has been opened and a follow-up report will be submitted after investigation.

Event Description

As reported: 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.

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
• Type of Device: 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
• MDR Text Key: 292043921
• Report Number: 2134812-2022-00029
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10841156108670
• UDI-Public: 10841156108670
• 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: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• Is the Device Single Use?: Yes
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 103 KG