MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ONCONTROL BIOPSY SYSTEM TRAY 152MM (BOX; BIOPSY NEEDLE KIT

Model Number	9466-VC-006
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: the account reported a needle break in a patient.On either thursday, march 2nd or friday, march 3rd, the oncontrol bone lesion biopsy system was used for a blb in the left iliac bone.The bone was sclerotic.Multiple bone biopsy samples were retrieved prior to having approximately 1cm of the distal cannula broken off in the iliac bone.Orthopedics were notified, and the decision was made to leave the piece of cannula embedded in the bone.No further medical/surgical intervention was performed.The patient's current condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.
Additional Manufacturer Narrative
(b)(4).Added lot number to section d: 51782623.One-unit of oncontrol kit was returned to vsi/teleflex for evaluation.The following components observed in the kit were: 2 ejector rods; 1 access cannula; 1 biopsy cannula.Damages were observed only on the biopsy cannula.Approximately 1.3 cm of the cannula shaft was missing.No damages were noted on other components.Unit is manufactured at viant medical.A device history record review was completed.All process steps were followed.Case details were reviewed.A patient underwent a blb procedure of the left iliac bone.Needle broke off in the patient.One unit of oncontrol kit was returned to vsi/teleflex for evaluation.Approximately 1.3 cm of the distal shaft of the biopsy cannula was missing.Additional information was requested.A response was received.Bone was sclerotic.Multiple bone biopsy samples were retrieved prior to having distal cannula broken off in the iliac bone.6 samples were obtained.No excessive force was applied.Two fluoroscopic images were shared that show cannula within the bone anatomy and a small piece left inside.It is likely due to anatomical factors and density of the bone, cannula could have fatigued and broken off.6 attempts and samples were taken prior to breakage.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.
Event or Problem Description
It was reported that: the account reported a needle break in a patient.On (b)(6), the oncontrol bone lesion biopsy system was used for a blb in the left iliac bone.The bone was sclerotic.Multiple bone biopsy samples were retrieved prior to having approximately 1cm of the distal cannula broken off in the iliac bone.Orthopedics were notified, and the decision was made to leave the piece of cannula embedded in the bone.No further medical/surgical intervention was performed.The patient's current condition is reported as fine.

• Brand Name: ONCONTROL BIOPSY SYSTEM TRAY 152MM (BOX
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16536555
• Report Number: 2134812-2023-00011
• Device Sequence Number: 20344349
• Product Code: FCG
• UDI-Device Identifier: 10816000012427
• UDI-Public: 10816000012427
• 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
• Serviced by Third Party (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): 03/06/2023

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: 11/18/2024
• Device Model Number: 9466-VC-006
• Device Catalogue Number: 9466-VC-006
• Device Lot Number: 51782623
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/28/2023
• 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
• Patient Sex: Unknown