MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ONCONTROL BIOPSY SYSTEM TRAY 102MM; BIOPSY NEEDLE KIT

Catalog Number	9408-VC-006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "needle broke and needed a "reverse" option" additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).No returned product evaluation could be completed as the product was not returned for this complaint.A dhr review was completed, and no issues or nonconformities were noted.Case details were reviewed.It is unknown stylet or cannula broke.Also, it is unknown where and how much of the cannula broke.Based on the limited information and no product evaluation, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: "needle broke and needed a "reverse" option" additional information has been requested from the account.

• Brand Name: ONCONTROL BIOPSY SYSTEM TRAY 102MM
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18814618
• Report Number: 2134812-2024-00006
• Device Sequence Number: 17229004
• Product Code: FCG
• UDI-Device Identifier: 10816000012267
• UDI-Public: 10816000012267
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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
• Device Catalogue Number: 9408-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: 02/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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: Unknown