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 Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "a piece of the needle broke off in a patient." additional information: "the procedure was a bone lesion biopsy of the right iliac crest.We received new biopsy guns within the last 6-8 months.A piece of needle broke off in patient's right iliac crest.Removed remaining product from patient, reported incident to hospital and contacted vendor." the patient was reported as fine/stable.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "a piece of the needle broke off in a patient." additional information: "the procedure was a bone lesion biopsy of the right iliac crest.We received new biopsy guns within the last 6-8 months.A piece of needle broke off in patient's right iliac crest.Removed remaining product from patient, reported incident to hospital and contacted vendor." the patient was reported as fine/stable.
Additional Manufacturer Narrative
(b)(4).The customer returned an access cannula, an access stylet, a biopsy cannula and one affected biopsy cannula.Blood particulates were noted on all units.The unit were decontaminated and inspected.Only the affected biopsy cannula exhibited shaft separation.It was noted upon product return that approximately 6.5 cm of shaft was missing.Distal end appeared to be damaged with stress.A dhr review was completed and no issues or nonconformities were noted.Case details were reviewed.Customer stated, "a piece of the needle broke off in a patient".As per the additional information received, the procedure was done on the right iliac crest.The separated piece was left inside the patient.The ifu along with the product states ''do not apply excessive force to driver/ needle set''.It is likely that the cannula was lodged into the bone due to anatomical conditions (sclerotic bone).However, no information on the bone conditions were provided.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context.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 27560
• MDR Report Key: 19215149
• Report Number: 2134812-2024-00018
• Device Sequence Number: 15188918
• Product Code: FCG
• UDI-Device Identifier: 10816000012380
• UDI-Public: 10816000012380
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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
• Device Catalogue Number: 9464-VC-006
• Device Lot Number: 73640734
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 73 YR
• Patient Sex: Male