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

Catalog Number	9466-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "we were completing a bone biopsy in an osteoid osteoma located in the posterior diaphyseal region of the tibia, on a pediatric sedated patient when an arrow oncontrol bone lesion biopsy needle broke off in the patient.Patient needed to go to surgery to have broken off part of needle removed.This required another sedation to patient.".
Additional Manufacturer Narrative
Qn# (b)(4).One-unit of oncontrol (lot: 73640824) was returned for evaluation.Blood particulates were noted on the unit.Unit was decontaminated and inspected.Approximately 1.7 cm of distal cannula was missing.The separated junction (distal cannula) was observed damaged.A dhr review was completed for lot 73640824 and no issues or non-conformities were noted.Case details were reviewed.One unit of cannula was returned to teleflex for evaluation.Approximately 1 cm of distal cannula was missing.The distal end was observed to be stressed.Additional information was requested.Procedure was bone biopsy of the osteoid osteoma located in the posterior diaphyseal region of the tibia.Patient condition is unknown outside of hospital care.Case to re attempted once the leftover piece is removed.The ifu states the following: do not apply excessive force to driver/ needle set.Stress at the distal junction is indicative of tip being subjected to resistance.Based on the information, the most likely root cause of the issue is operational context.
Event or Problem Description
It was reported that: "we were completing a bone biopsy in an osteoid osteoma located in the posterior diaphyseal region of the tibia , on a pediatric sedated patient when an arrow oncontrol bone lesion biopsy needle broke off in the patient.Patient needed to go to surgery to have broken off part of needle removed.This required another sedation to patient.".

• Brand Name: ONCONTROL
• 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: 20154752
• Report Number: 2134812-2024-00046
• Device Sequence Number: 8368997
• Product Code: FCG
• UDI-Device Identifier: 10841156108625
• UDI-Public: (01)10841156108625(11)231101(17)261031(10)73640824(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: 9466-VC-006
• Device Lot Number: 73640824
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/18/2024
• 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 Sex: Unknown