MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA; 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	07/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "pt was having a bone lesion biopsy, during procedure specimen was unable to be obtained.When attempting to adjust the cannula with the drill, the cannula broke from the plastic hub that sits in the drill, leaving the cannula in the patient.The cannula was unable to be removed with manual traction." ai received on 11jul2024: pt had to go to or with orthopedic surgeon, surgeon used trephine drill to remove broken cannula.When using the drill, cannula broke again inside the patient.Remaining fragment of cannula was able to be removed with further drilling using the trephine drill.Pt did not experience any significant blood loss.Closure was performed and pt was kept overnight for observation.Pt was discharged the following day.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "pt was having a bone lesion biopsy, during procedure specimen was unable to be obtained.When attempting to adjust the cannula with the drill, the cannula broke from the plastic hub that sits in the drill, leaving the cannula in the patient.The cannula was unable to be removed with manual traction." ai received on 11jul2024: pt had to go to or with orthopedic surgeon, surgeon used trephine drill to remove broken cannula.When using the drill, cannula broke again inside the patient.Remaining fragment of cannula was able to be removed with further drilling using the trephine drill.Pt did not experience any significant blood loss.Closure was performed and pt was kept overnight for observation.Pt was discharged the following day.
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.Oncontrol kit is supplied by viant.A dhr review was completed was lot 63844601.Case details were reviewed.As per the additional information received, the location was right iliac crest.Bone was sclerotic.Driver was used with downward pressure.Patient had to go into the or for the surgery to remove the broken cannula.A trephine drill was used.The cannula broke again.The remaining fragment was removed from the patient.Patient was kept for observation and discharged next day.It is likely that the cannula was lodged into a very dense sclerotic bone.The torque applied could have transmitted to shaft causing it break when there is no movement of the cannula.No fluoroscopic pictures of the bone were shared.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 is undeterminable.The der process will continue to monitor for any similar events.

• Brand Name: ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA
• 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: 19903860
• Report Number: 2134812-2024-00033
• Device Sequence Number: 21015546
• Product Code: FCG
• UDI-Device Identifier: 10841156108588
• UDI-Public: (01)10841156108588(11)221103(17)251101(10)63844601(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 07/09/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Catalogue Number: 9464-VC-006
• Device Lot Number: 63844601
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/05/2024
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 77 KG