MAUDE Adverse Event Report: MICROPORT NEROTECH(SHANGHAI)CO.,LTD NUMEN; NUMEN COIL EMBOLIZATION SYSTEM

Model Number	3D0410FN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the images, videos and specified info provided, it is supposed that unfavorable detachment environment on the site caused the failure detachment.As devices were not sent back, we can not perform further analysis to comfirm the specific cause of the failure.
Event or Problem Description
During case the physicians deployed 2 successful coils into aneurysm with no issues.On third coil, the physicians had detachment zone of coil properly lined up, and heard the 3 beeps for successful detachment, physician pulled back as well to make sure detachment occurred and during that time nothing was seen so successful detachment was assumed.When pulling out microcatheter the physicians realized coil was not detached and at that point physician tried to move coil but it was not able to advance or pull back, almost stuck.Finally when the detachment zone was past marker the end of the coil popped out leaving a tail in the vessel.An lvis jr 3.5x14 was placed to tack the coil down.This adverse events was due to coil did not detach properly and resulted in tail of coil in ica vessel and a stent was needed to tack it down, and there is no death or injury involved in this case.

• Brand Name: NUMEN
• Common Device Name: NUMEN COIL EMBOLIZATION SYSTEM
• Manufacturer (Section D): MICROPORT NEROTECH(SHANGHAI)CO.,LTD; 1661 zhangdong rd.; zj hi-tech park; shanghai, 20120 3; CH 201203
• Manufacturer (Section G): MICROPORT NEUROTECH (SHANGHAI) CO.,LTD; 1661 zhangdong rd.; zj hi-tech park; shanghai, 20120 3; CH 201203
• Manufacturer Contact: yuanyuan chen ; 1661 zhangdong rd.; zj hi-tech park; shanghai, 20120-3 ; CH 201203
• MDR Report Key: 16500251
• Report Number: 3016609702-2023-00001
• Device Sequence Number: 15027071
• Product Code: HCG
• UDI-Device Identifier: 06958698011461
• UDI-Public: (01)06958698011461(17)240316(10)11460002(91)003
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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?: No
• Device Expiration Date: 03/16/2024
• Device Model Number: 3D0410FN
• Device Lot Number: 11460002-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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: Required Intervention
• Patient Sex: Unknown