MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC BIOPSY SYSTEM COMPREHENSIVE TRAY 102MM(B; BIOPSY NEEDLE KIT

Catalog Number	9458-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during a bone marrow biopsy on a patient with a 4" needle.He had extremely hard bones.We were able to get into the aspirate manually and got liquid aspirate.When trying to use the driver to obtain a core, the needle bent at the orange part.When trying to retract the driver, the orange piece snapped off the needle.After using a kelly clamp, we were able to remove the needle.However, it appears that the tip of the bore needle was not fully intact.The patient was reported as fine post the procedure." additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn #: (b)(4).No return product evaluation could be completed as the device was not returned for investigation.It is unknown if any damages were present on the unit.A device history record review was performed, and no relevant findings were identified.Based on the information, the most likely root cause of the issue is undeterminable.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "during a bone marrow biopsy on a patient with a 4" needle.He had extremely hard bones.We were able to get into the aspirate manually and got liquid aspirate.When trying to use the driver to obtain a core, the needle bent at the orange part.When trying to retract the driver, the orange piece snapped off the needle.After using a kelly clamp, we were able to remove the needle.However, it appears that the tip of the bore needle was not fully intact.The patient was reported as fine post the procedure." additional information has been requested from the account.
Event or Problem Description
It was reported that: "during a bone marrow biopsy on a patient with a 4" needle.He had extremely hard bones.We were able to get into the aspirate manually and got liquid aspirate.When trying to use the driver to obtain a core, the needle bent at the orange part.When trying to retract the driver, the orange piece snapped off the needle.After using a kelly clamp, we were able to remove the needle.However, it appears that the tip of the bore needle was not fully intact.The patient was reported as fine post the procedure." additional information has been requested from the account.
Additional Manufacturer Narrative
Qn #: (b)(4).Correction to section d: udi number.The udi number has been updated from (b)(4) to (b)(4).

• Brand Name: BIOPSY SYSTEM COMPREHENSIVE TRAY 102MM(B
• 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: 21846976
• Report Number: 2134812-2025-00012
• Device Sequence Number: 12753441
• Product Code: FCG
• UDI-Device Identifier: 10841156108502
• UDI-Public: (01)10841156108502(11)240625(17)270619(10)77911705(21)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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 Catalogue Number: 9458-VC-006
• Device Lot Number: 77911705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/19/2025; 05/19/2025
• 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; NOT REPORTED
• Patient Sex: Unknown