MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ONCONTROL COAXIAL BIOPSY TRAY 10/12 GA; 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	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "osteoid osteoma in the femur.Went in with green introducer.Followed with orange needle.Was taking 1/2 cm samples.Was advancing needle and then orange hub snapped off.Physician was able to remove green introducer and then had ortho come in to help remove remaining needle.About 1 cm of distal biopsy needle was left behind in the bone.The tip of the biopsy needle is in the patients bone.The patient is fine.
Additional Manufacturer Narrative
(b)(4).One-unit of oncontrol cannula was returned to teleflex for evaluation.Minor blood particulates were noted on the unit.The shaft was split into 3 pieces.All the pieces put together measure 7 cm.Approximately 7.5 cm of shaft was missing.The returned pieces were severely damaged.Hub separation was also noted.Polymer material was observed to be scrapped within the hub.Viant is supplier for oncontrol.A dhr review was completed for lot 73640658.No issues or nonconformities were noted.Additional information was requested.Procedure was performed on the osteoid osteoma of femur.Access needle went inside.The cannula that passes via the access needle broke off at the hub.The physician had to remove rest of the shaft.Approximately 1 cm of the cannula was left inside the bone.Patient is fine.Based on the product return, the polymer scraped is indicative of operation against resistance.Per ifu, states the following: do not apply excessive force to driver/ needle set.It is likely that damages noted on the cannula shaft are induced pa rtially during insertion and mostly at removal from bone anatomy.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: "osteoid osteoma in the femur.Went in with green introducer.Followed with orange needle.Was taking 1/2 cm samples.Was advancing needle and then orange hub snapped off.Physician was able to remove green introducer and then had ortho come in to help remove remaining needle.About 1 cm of distal biopsy needle was left behind in the bone.The tip of the biopsy needle is in the patients bone.The patient is fine.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18920214
• Report Number: 2134812-2024-00008
• Device Sequence Number: 6410567
• Product Code: FCG
• UDI-Device Identifier: 10816000012366
• UDI-Public: 10816000012366
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Catalogue Number: 9463-VC-006
• Device Lot Number: 73640658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/05/2024
• 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 Age: 43 YR
• Patient Sex: Male