MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA; INSTRUMENT BIOPSY

Catalog Number	9462-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " patient's lesion was on 9th rib.(b)(6) was using oncontrol to get the samples.During the procedure, he made total of 4 attempts to get the samples with oncontrol.The needle is out from patient's body after the procedure.They did a ct scan and found out the access needle (orange needle) was broken and left inside patient's body (9th rib).The length of the needle that left in the body is estimated 0.5cm.The needle tip is still in the patients body.There is no plan at present to remove it.There is no reported health consequence from the needle tip.".
Additional Manufacturer Narrative
(b)(4).Device evaluation: the complaint sample was received at our manufacturing site for evaluation.The customer returned an access cannula, an access stylet, an access ejector set 11 gauge, a cannula ejector set 13 gauge, a transfer rod and an affected cannula.Blood particulates were noted on all units.Units were decontaminated and inspected.Approximately 4.4 mm of cannula tip was separated.The remaining shaft was intact with the distal shaft damaged.The distal shaft was observed to have stress marks.A dhr review was completed for lot 70029785 and no issues or non-conformities were noted.Case details were reviewed.Additional information received indicates that the lesion was located on the left 9th rib, with a thick, hard cortex and calcification.The tip of the biopsy needle broke off and was left within the lesion.A second biopsy needle was used to successfully obtain the core sample.It was confirmed that no excessive force was applied to the driver during the procedure.A fluoroscopic image was provided, confirming that the needle tip remained lodged within the anatomy.Additionally, the ifu indicates that the arrow oncontrol bone lesion biopsy system is intended for bone biopsy of the vertebral body and bone lesions.The procedure was performed off label use.It is likely that the shaft became fatigued due to multiple biopsy attempts.Stress marks observed on the shaft suggest the cannula was subjected to resistance and torque.The tip separation is likely attributable to the fatigued shaft and the anatomical conditions encountered during the procedure.Based on the information, the most likely root cause of the issue is operational context and/or user error.
Event or Problem Description
It was reported that " patient's lesion was on 9th rib.Dr (b)(6) was using oncontrol to get the samples.During the procedure, he made total of 4 attempts to get the samples with oncontrol.The needle is out from patient's body after the procedure.They did a ct scan and found out the access needle (orange needle) was broken and left inside patient's body (9th rib).The length of the needle that left in the body is estimated 0.5cm.The needle tip is still in the patients body.There is no plan at present to remove it.There is no reported health consequence from the needle tip.".

• Brand Name: ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA
• Common Device Name: INSTRUMENT BIOPSY
• 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: 20143702
• Report Number: 2134812-2024-00044
• Device Sequence Number: 8368648
• Product Code: KNW
• UDI-Device Identifier: 10841156108540
• UDI-Public: (01)10841156108540(11)230524(17)260523(10)70029785(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 08/14/2024

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 Expiration Date: 05/23/2026
• Device Catalogue Number: 9462-VC-006
• Device Lot Number: 70029785
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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
• Patient Age: 20 YR
• Patient Sex: Unknown