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

Catalog Number	9464-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: the access needle broke in the patient's pelvis during the biopsy and had to be removed surgically.The procedure was successful, and the entirety of the needle was recovered.The patient is fine.
Event or Problem Description
It was reported that: the access needle broke in the patient's pelvis during the biopsy and had to be removed surgically.The procedure was successful, and the entirety of the needle was recovered.The patient is fine.
Additional Manufacturer Narrative
(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.Viant is the supplier for on control units.A dhr review was requested for 70792624.All processes were followed.No nonconformances were noted.Case details were reviewed.Customer stated, "the access needle broke in the patient's pelvis during the biopsy and had to be removed surgically." no unit was returned to teleflex for evaluation.It is unknown where exactly the cannula broke.Additional information was requested.No information was received.It is unknown to what extent, degree, or rigor this device has seen use and handling.A manufacturing record review was completed by viant and no related nonconformances were found.Based on the limited information, the most likely root cause of the issue was undeterminable.The der process will continue to monitor for any similar events.

• 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: 17823857
• Report Number: 2134812-2023-00051
• Device Sequence Number: 20384775
• Product Code: FCG
• UDI-Device Identifier: 10816000012380
• UDI-Public: 10816000012380
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 9464-VC-006
• Device Lot Number: 707926624
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 11/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown