MAUDE Adverse Event Report: Elucent Medical SmartClip Introducer

Model Number	SMARTCLIP
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During deployment of the marker, customer reported that the introducer was fully deployed into the patient and no marker was seen in the subsequent imaging.A secondary introducer with marker was utilized and placed sucessfully.
Additional Manufacturer Narrative
On 28jul2026 uci health chao family comprehensive cancer center reported a deployment issue involving a crown retention feature pink 10cm smartclip.Imaging performed after fully deploying the introducer used in this case confirmed no clip was deployed.The introducer used in this case was not returned and an on-site analysis was unable to be performed.Additionally, no images of the introducer were provided for review.Though the device was not returned for inspection and images of the device were not provided, it is likely the introducer did not contain a smartclip as no evidence of a smartclip being present in the packaging or surrounding deployment area were reported.A review of records identified no manufacturing nonconformances, process deviations, scrap or other issues that could have contributed to the reported event.As no other contributing factor could be identified through this investigation, manufacturing error remains the most probable root cause.

• Brand Name: SmartClip Introducer
• Common Device Name: SmartClip
• Manufacturer (Section D): Elucent Medical; 6509 flying cloud drive; suite 160; eden prairie MN 55344 -330
• Manufacturer Contact: shannon bensend ; 6509 flying cloud drive; suite 160, MN 55344--330 ; +1(651)895-4049
• MDR Report Key: 50464287
• Report Number: 3014653199-2026-00003
• Device Sequence Number: 10197811
• Product Code: NEU
• UDI-Device Identifier: 00851674008263
• UDI-Public: (01)00851674008263
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K18640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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 Model Number: SMARTCLIP
• Device Catalogue Number: SMARTCLIPLT-PNK-10
• Device Lot Number: 11597192
• 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: Not provided
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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