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

Model Number	KCLT-06
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
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 complaint had not been previously reported.The device was not returned to vasorum ltd.For examination.It was subsequently reported that the implant was explanted, and 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
The following was reported through medwatch (mw5177699) "after a left heart catheterization, it was decided to use a closure device to close the femoral arteriotomy.During deployment of celt 6f device, the footplate broke off and embolized down the leg.Required vascular surgery intervention to remove the footplate".Follow up investigation indicated the impant was embolized.Snare retrieval was unsuccessful.The implant was successfully removed surgically.The patient was stable after the surgery and discharged the next day.

• Brand Name: CELT ACD VASCULAR 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: 23665446
• Report Number: 3009984513-2025-00010
• Device Sequence Number: 16017457
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)280114(10)943220
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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-06
• Device Lot Number: 943220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 84 KG