MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ONCONTROL COAXIAL BIOPSY TRAY; BIOPSY NEEDLE KIT

Catalog Number	9463-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: the distal piece of the oncontrol biopsy cannula broke off in a patient's skull during a bone biopsy.No medical or surgical intervention was performed.It was reported that the patient was fine post the procedure.
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: the distal piece of the on control biopsy cannula broke off in a patient's skull during a bone biopsy.No medical or surgical intervention was performed.It was reported that the patient was fine post the procedure.
Additional Manufacturer Narrative
Qn# (b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.A dhr review was done by the supplier.All processes were followed.No non conformances were noted.Case details were reviewed.Customer stated" ct tech said an oncontrol needle broke off in a patient's skull".No unit was returned to teleflex for evaluation.It is unknown what damages have occurred on the unit and how much of the shaft was separated and left behind in the anatomy.Additional information was requested.A response was received.Procedure was a skull bone lesion biopsy.No excessive force was applied.No notable change in the rpm of the driver was observed.Device was removed but the distal piece was left behind in the anatomy.No intervention was performed nor any harm, injury was noted.Per the additional information, the unit was used in an unintended location.Per ifu, the arrow oncontrol bone lesion biopsy system is intended for bone biopsy of the vertebral body and bone lesions.A manufacturing record review was completed by the supplier and no related nonconformances were found.Without a product return and limited information, the most likely root cause if the issue is undeterminable.

• Brand Name: ONCONTROL COAXIAL BIOPSY TRAY
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17224899
• Report Number: 2134812-2023-00028
• Device Sequence Number: 15255738
• 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): 06/02/2023

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 Catalogue Number: 9463-VC-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male
• Patient Weight: 159 KG