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

Catalog Number	9408-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer stated that when they were doing the procedure, in the posterior iliac crest the cannula became stuck, and the hub came off.There was no redirect attempted or excessive pressure.They had tried using kelly clamps to wiggle out the cannula without success.They had also contacted ortho to assist them in removal.During the attempted removal by ortho , the cannula broke off inside the patient's bone.It was reported that the iliac crest lesion was very hard and organized.Patient is stable and discharged, 2.5 cm of cannula left in bone, patient procedure aborted.At the time of discharge there was no plan for another medical intervention to remove the cannula.
Event or Problem Description
Customer stated that when they were doing the procedure, in the posterior iliac crest the cannula became stuck, and the hub came off.There was no redirect attempted or excessive pressure.They had tried using kelly clamps to wiggle out the cannula without success.They had also contacted ortho to assist them in removal.During the attempted removal by ortho , the cannula broke off inside the patient's bone.It was reported that the iliac crest lesion was very hard and organized.Patient is stable and discharged, 2.5 cm of cannula left in bone, patient procedure aborted.At the time of discharge there was no plan for another medical intervention to remove the cannula.
Additional Manufacturer Narrative
(b)(4) one-unit of oncontrol cannula was returned to teleflex for evaluation.Minor blood particulates were noted.The shaft was observed to be separated into multiple pieces.Each piece was severely damaged.A part of the shaft, approximately 2.5 cm was observed to be missing.Viant is the supplier of oncontrol kit.A dhr review was completed by viant.No issues or non-conformances were noted.Case details were reviewed.Customer stated, "biopsy needle stuck in iliac crest." the shaft was observed to be separated into multiple pieces.Each piece was severely damaged.Approximately 2.5 cm was observed to be missing.The procedure was done in the ir lab.A picture was shared by the customer.The hub was noted to be missing with minor damages at the proximal end of the shaft.Customer stated that bone was used in a lesion.The lesion in the iliac crest was hard and organized.The ifu states the following: the arrow oncontrol bone marrow aspiration system is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients - - do not apply excessive force to driver/needle set upon attempting to remove the needle with clamps, shaft separation was noted.A part of the cannula was left in the bone.No additional surgery is planned for removal.Patient is stable.A manufacturing record review was completed by viant and no related nonconformances were found.The damages to the shaft are likely to have occurred during removal of the cannula.The unit was used off label in a lesion condition.Based on the information, the most likely root cause of the issue is user error.The der process will continue to monitor for any similar events.

• Brand Name: ARROW 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18254417
• Report Number: 2134812-2023-00055
• Device Sequence Number: 6644146
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9408-VC-006
• Device Lot Number: 71055468
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/16/2024
• 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: 60 YR
• Patient Sex: Male