MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ONCONTROL COAXIAL BIOPSY TRAY 10/12 GA; BIOPSY NEEDLE KIT

Catalog Number	9465-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "right tibial diaphysis osteoid osteoma rf ablation.The on control device was used to drill through the bone to obtain access to the lesion for the ablation probe.The cortex of the bone was very dense and notably difficult to traverse.The device was used in pulse trigger fashion.The inner 12g needle and tip of 10g needle fractured during use and was retained in the patient.It was eventually retrieved with an orthopedic trephine needle extractor set.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).Fractured pieces of oncontrol shaft were returned for evaluation.3 pieces were returned.Blood particulates were noted.The pieces were decontaminated and inspected.Both needle and biopsy sets were severely fractured that an accurate dimensional measurement was not possible.Viant is the supplier for oncontrol.A device history record (dhr) review was completed for lot 75941067.No issues or nonconformities were noted.Case details were reviewed.Customer stated, "right tibial diaphysis osteoid osteoma rf ablation.The oncontrol device was used to drill through the bone to obtain access to the lesion for the ablation probe.The cortex of the bone was very dense and notably difficult to traverse.The device was used in pulse trigger fashion.The inner 12g needle and tip of 10g needle fractured during use and was retained in the patient.It was eventually retrieved with an orthopedic trephine needle extractor set." 3 fractured small pieces of oncontrol shaft were returned for evaluation.The pieces were observed to be severely damaged.Additional information was requested.A response was received.Per customer both inner 12g and outer 10g fractured.Customer is unsure if excessive force was applied.Patient condition is fine.Per instructions for use (ifu) states the following: indications for use: the arrow oncontrol bone lesion biopsy system is intended for bone biopsy of the vertebral body and bone lesions.Do not apply excessive force to driver/ needle set.Procedure was done in a tibial site and is considered offlabel use.Damages observed indicate the cannula was subjected to excessive stress leading to fracture.This likely due to the anatomical conditions (density of bone).A manufacturing record review was completed by viant and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and user error.The der process will continue to monitor and investigate any similar events.
Event or Problem Description
It was reported that "right tibial diaphysis osteoid osteoma rf ablation.The oncontrol device was used to drill through the bone to obtain access to the lesion for the ablation probe.The cortex of the bone was very dense and notably difficult to traverse.The device was used in pulse trigger fashion.The inner 12g needle and tip of 10g needle fractured during use and was retained in the patient.It was eventually retrieved with an orthopedic trephine needle extractor set.The patient was reported as fine post the procedure.".

• Brand Name: ONCONTROL COAXIAL BIOPSY TRAY 10/12 GA
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21110614
• Report Number: 2134812-2025-00002
• Device Sequence Number: 15643384
• Product Code: FCG
• UDI-Device Identifier: 10841156108601
• UDI-Public: (01)10841156108601(11)240320(17)270319(10)75941067(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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 Catalogue Number: 9465-VC-006
• Device Lot Number: 75941067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown