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

Model Number	9463-VC-006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.
Event or Problem Description
It was reported that: lesion needle broke off in patients' bone during an osteoid osteoma bone biopsy.The physician states he thought the needle bent when trying to get the biopsy sample and the driver would not spin to drive in or out.Additional information: the estimated length of the device embedded in the patient's leg bone was 1-2cm, the bone was reported as being sclerotic.The orthopaedic surgeon pulled out the fragment and the patient was described as fine post the procedure.
Additional Manufacturer Narrative
Qn#(b)(4).A small portion of the oncontrol cannula was returned to vsi/teleflex for evaluation.Minor blood particulates were noted on the unit.The piece measured approximately 1.5 cm.The shaft of the piece was twisted and damaged.A dhr review was requested.All processes were followed.No nonconformances were noted.Case details were reviewed.A patient underwent a bone biopsy of an osteoid osteoma.Needle broke off in the patient bone.A small portion of oncontrol cannula was returned to vsi/teleflex for evaluation.The piece measured 1.5 cm.The shaft of the piece was twisted and damaged.Additional information was requested.A response was received.Bone location was the leg, and it was sclerotic.It is unknown if excessive force was applied.A notable change in the rpm was noted.The piece was removed by the surgeon.Patient condition is fine.Per ifu states the following - do not apply excessive force to driver/ needle set.Damages are likely to have occurred during use when operated against a sclerotic lesion.Physician stated that he thought the needle bent when trying to get a biopsy.A manufacturing record review was completed by the manufacturer 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: lesion needle broke off in patients' bone during an osteoid osteoma bone biopsy.The physician states he thought the needle bent when trying to get the biopsy sample and the driver would not spin to drive in or out.Additional information: the estimated length of the device embedded in the patient's leg bone was 1-2cm, the bone was reported as being sclerotic.The orthopaedic surgeon pulled out the fragment and the patient was described as fine post the procedure.

• 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: 16884412
• Report Number: 2134812-2023-00018
• Device Sequence Number: 20368483
• Product Code: FCG
• UDI-Device Identifier: 10841156108564
• UDI-Public: 10841156108564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2025
• Device Model Number: 9463-VC-006
• Device Catalogue Number: 9463-VC-006
• Device Lot Number: 59433127
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown