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

Model Number	CLT-05
Medical Device Problem Codes	Migration (4003); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
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.The patient was stable post procedure and discharged the following day.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.
Event or Problem Description
It was reported that the physician attempted closure with 5f celt acd plus.During closure the operator performed step 1 and 2 of deployment under ultrasound guidance and utilizing the blood signal, but when attempted to eject/detach the implant the lever wouldn't move with the usual force applied.Operator then increased the pressure and the implant detached and migrated downstream, becoming lodged in a side branch of the superficial femoral artery.The closure procedure was completed with manual pressure and hemostasis was achieved.Patient was stable and discharged same day.

• Brand Name: CELT ACD VASCULAR CLOSURE DEVICE
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): VASORUM LTD; 2012 ochard avenue; citywest business campus; dublin, D24WP W6; EI D24WPW6
• Manufacturer (Section G): VASORUM LTD; 2012 orchard avenue; citywest business campus; dublin, D24WP W6; EI D24WPW6
• Manufacturer Contact: 2012 orchard avenue; citywest business campus; dublin, D24WP-W6
• MDR Report Key: 24673375
• Report Number: 3009984513-2026-00005
• Device Sequence Number: 21403900
• Product Code: MGB
• UDI-Device Identifier: 05391530280617
• UDI-Public: (01)05391530280617(17)281209(10)943609
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2025
• Device Model Number: CLT-05
• Device Lot Number: 943609
• 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: 02/12/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2025
• 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: Other
• Patient Sex: Male