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

Model Number	KCLT-06
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.A search of the complaint files did not find any other report with the lot number (943124).The device was not returned to vasorum ltd.For examination.Attempts to obtain final patient status were unsuccessful other than it being reported that the snaring procedure was successful.It was not determined if the hospital had actually submitted the medwatch report to the fda.As the time of closing out this event, vasorum ltd did not identify or receive any official fda medwatch correspondence.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
A medwatch report form was received which stated that the 6f celt acd closure device was mal-deployed and intraluminal in the right common femoral artery.The mal-deployed closure device was immediately retrieved successfully.An update was received on (b)(6) 2025 informing that the embolized implant was retrieved successfully by a snare.Attempts to obtain final patient status were unsuccessful.

• 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, 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: 22183532
• Report Number: 3009984513-2025-00007
• Device Sequence Number: 18289676
• Product Code: MGB
• UDI-Device Identifier: 05391530280679
• UDI-Public: (01)05391530280679(17)270604(10)943124
• 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): 06/11/2025

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-06
• Device Lot Number: 943124
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/11/2025
• 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: Female
• Patient Weight: 62 KG