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

Catalog Number	9458-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during a biopsy of a right iliac crest.The physician used the same bmb tray on two separate lesion sites instead of using the blb tray, lesions were sclerotic.Patient did fine but lower half of needle left in patients' hip.No surgery required, and no extended stay was required.
Additional Manufacturer Narrative
(b)(4).One-unit of oncontrol was returned to teleflex for evaluation.Blood particulates were noted on the unit.The tip separation of the cannula shaft was confirmed.Per subassembly, the shaft length was observed to be 3.79 +/- 0.10 inches (93.7 mm - 98.8 mm).Approximately, 0.5 - 1 cm of distal tip was missing.Viant is the supplier for oncontrol needles.A dhr review was completed.No issues or non-conformances were noted.All processes were followed.Case details were reviewed.Customer stated "tech believes physician used marrow needle on lesion site and then used same needle on different site to obtain marrow sample." additional information was requested.A response was received.The bone was sclerotic.Physician was using a bmb kit on a hard bone lesion biopsy.Per 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.The arrow oncontrol bone marrow biopsy system is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients.The needle was used twice at two different lesion sites.Distal part of the needle was left inside the patient during the second attempt.Site was the right iliac crest.Procedure was aborted.No additional intervention was performed.A manufacturing record review was completed by viant and no related nonconformances were found.Based on the information, the most likely root cause of the issue is user error.
Event or Problem Description
It was reported that: during a biopsy of a right iliac crest.The physician used the same bmb tray on two separate lesion sites instead of using the blb tray, lesions were sclerotic.Patient did fine but lower half of needle left in patients' hip.No surgery required, and no extended stay was required.

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17601740
• Report Number: 2134812-2023-00042
• Device Sequence Number: 15004270
• Product Code: FCG
• UDI-Device Identifier: 10816000012304
• UDI-Public: 10816000012304
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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: 9458-VC-006
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/29/2023
• 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 Sex: Unknown