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

Model Number	KCLT-05
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 5f celt device was used to closed a 5f arterial puncture.Upon ejection of the implant it was noted that the closure didn't work and manual compression was applied.During the manual compression step, the attending physician elected to retrieve the implant by accessing the opposite groin to go up and over and snare the implant.The physician was able to complete snaring of implant successfully with no adverse events/complications to the patient.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.The patient required an additional snare procedure to remove the embolized implant.The physician was able to do so successfully with no adverse event/complications to the patient.A search of the complaint files did not find any other report with the lot number (943101).The device was not returned to vasorum ltd.For examination.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 unless requested by the fda.

• Brand Name: CELT ACD VASCULAR CLOSURE DEVICE
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): VASORUM LTD.; 2012 orchard 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: 21362097
• Report Number: 3009984513-2025-00003
• Device Sequence Number: 8465271
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)270415(10)943101
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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 Model Number: KCLT-05
• Device Lot Number: 943101
• 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: 02/05/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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: Male