MAUDE Adverse Event Report: COOK INC CHIBA BIOPSY NEEDLE

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: mjg.Initial reporter, customer (person), phone, email: (b)(6).Pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a chiba biopsy needle separated during a thoracic vertebral cementoplasty procedure, leaving behind a fragment in the patient's soft tissue.The device was first used without issue to inject local anesthesia and as a guide for placement for vertebroplasty.Following, it was reported that the "placement of the trocar on the chiba, after removal of the coaxial, could not be carried out entirely with a blockage during the progression of the trocar".Immediately after device removal, follow-up imaging revealed a distal portion of the device in the patient's soft tissue.As a result, the patient was later administered general anesthesia and the fragment was removed by an orthopedic surgeon without any complications.As the patient had no one to carry out necessary monitoring after general anesthesia, they were hospitalized.No other adverse effects have been reported.Additional information regarding event clarification and formal translation, as well as device and event details, has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There were no issues advancing the needle.It was confirmed that the outer trocar was the device component that separated.Imaging provided by the facility shows a device fragment remaining in the soft tissue of the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: (b)(6) in france contacted cook stating that during a cementoplasty procedure, the distal tip of the chiba needle [dchn-20-20.0] broke off and was left in the patient.The patient required surgical intervention to remove the part of the needle that had broken off.There were no additional adverse effects for the patient.Another needle was used to complete the cementoplasty procedure.The product is from lot# 13874368.A review of the complaint history, device history record, drawing, and quality control, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The device was returned to cook for evaluation.Evaluation showed that the hub was separated from the cannula and that the distal tip was broken off.The outer diameter of the needle measured within specification.The inner diameter could not be measured due to damage.Additionally, a document based investigation evaluation was performed.There are process checks during the manufacturing process to identify non-conforming product and prevent non-conforming product from leaving house.The device history record for lot# 13874368 was reviewed.Lot# 13874368 did not have any relevant non-conformances.Needle subassembly lots sa13829123 and sa13829124 were reviewed and did not have any non-conformances.There are no additional complaints for this lot.There is no evidence of non-conforming material in house or in the field.Based on the device master record, the device history record, and the device failure analysis, there is no indication the device was manufactured out of specification.Based on the information provided, inspection of returned product and the results of the investigation, the cause of this event is component failure.There is no evidence of manufacturing deficiency.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CHIBA BIOPSY NEEDLE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12488401
• Report Number: 1820334-2021-02165
• Device Sequence Number: 19733577
• Product Code: MJG
• UDI-Device Identifier: 00827002008106
• UDI-Public: (01)00827002008106(17)260406(10)13874368
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2022

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: 04/06/2026
• Device Model Number: N/A
• Device Catalogue Number: DCHN-20-20.0
• Device Lot Number: 13874368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 02/09/2022
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 12/01/2021; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown