MAUDE Adverse Event Report: VASORUM LTD CELT ACD PLUS VASCULAR CLOSURE DEVICE

Model Number	CLT-05
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medsun that a celt plus 5f implant was embolized on release from the delivery system into a branch of the common femoral artery.The position of the implant in the side branch was stable, and the location was deemed by the operator not to be harmful for the patient.No attempt was made to retrieve the implant.The patient was informed and had no symptoms.Haemostasis was achieved by manual pressure.
Additional Manufacturer Narrative
During processing of this complaint an attempt was made to obtain complete event information.A search of the complaint files was completed, and no other complaints were identified with the same lot number.The device was not returned to vasorum ltd for examination.The implant remains in the patient.This incident resulted in no patient harm as no further procedure was required and the patient had no symptoms.All available information has been placed on file in the customer complaint files of vasorum ltd.For appropriate tracking, trending and follow-up.No corrective/preventative actions will be taken at this time.This report is the final report being submitted by vasorum ltd.

• Brand Name: CELT ACD PLUS VASCULAR CLOSURE DEVICE
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): VASORUM LTD; 2012 orchard avenue; citywest business campus; dublin, co. dublin D24WP W6; EI D24WPW6
• Manufacturer (Section G): VASOURM LTD; 2012 orchard avenue; citywest business campus; dublin, co. dublin D24WP W6; EI D24WPW6
• Manufacturer Contact: 2012 orchard avenue; citywest business campus; dublin, co. dublin D24WP-W6
• MDR Report Key: 25123673
• Report Number: 3009984513-2026-00006
• Device Sequence Number: 18823662
• Product Code: MGB
• UDI-Device Identifier: 05391530280617
• UDI-Public: (01)05391530280617(17)281022(10)943577
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150006
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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 Model Number: CLT-05
• Device Lot Number: 943577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown