MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC ONCONTROL® BONE MARROW BIOPSY SYSTEM TRAY, 152MM (6/BX); BIOPSY NEEDLE KIT

Model Number	9402-VC-006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been opened to review device history record and risk documentation.A follow-up report will be submitted after investigation.
Event or Problem Description
As reported: physician used oncontrol bone marrow system needle (3.0mmx152mm) with oncontrol power driver.While coming out from the lesion, the distal locking assembly of the aforementioned needle gave away from the attached power drill, resulting in the breakage of the cannula at sub trochanteric entry point.The proximal part of the cannula is stuck between the subtrochanteric region and the head of the femur.Trocar and extra-osseous part of the broken cannula were removed.The patient was treated in mumbai and is back in delhi with a part of the needle in the bone.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Angiogram images of the issue was sent by the account.It can be noted that the shaft of the cannula was left within the anatomy of the bone.The device history record was reviewed, and no non-conformances were noted.All records were in accordance with the device manufacturing record requirements.Case details were reviewed.The proximal hub appears to be missing.Per ifu indications for use, the following is stated: - the arrow® oncontrol® bone marrow aspiration system is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients.The arrow® oncontrol® bone marrow biopsy system is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients based on the event details, the bone marrow biopsy system is used in an incorrect anatomical region (lesion in head of femur).Additional information was requested.A response was received.Cannula is stuck between the subtrochanteric region and head of femur.Trocar and extraosseus part of the broken cannula was removed.No other surgical notes or operational use of oncontrol units were shared.Procedure was aborted due to this event.Based on the information, the most likely root cause of the issue is user error.

• Brand Name: ONCONTROL® BONE MARROW BIOPSY SYSTEM TRAY, 152MM (6/BX)
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 12209890
• Report Number: 2134812-2021-00051
• Device Sequence Number: 14235570
• Product Code: FCG
• UDI-Device Identifier: 30816000012230
• UDI-Public: 30816000012230
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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 Expiration Date: 09/09/2023
• Device Model Number: 9402-VC-006
• Device Lot Number: 39647270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 11/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown