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

Model Number	KCLT-07
Medical Device Problem Codes	Off-Label Use (1494); Malposition of Device (2616)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/25/2025
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 (943286).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 intial report being submitted by vasorum ltd.
Event or Problem Description
It was reported that physician used a 7f celt acd plus device to close an 8f arteriotomy after a 4-hour coronary cto procedure.The device was retracted to what was thought to be the arteriotomy after the distal wing was deployed.Upon raising to 90 degrees the blood signal did not completely stop so physician made multiple attempts to retract further and elevate again.The blood signal appeared to stop.Upon deployment of the proximal wing the device appeared to jump upward slightly.Implant was ejected, bleeding was noted and manual compression was used to achieve hemostasis for approximately 1 hour.The physician elected to give a blood transfusion since the patient was becoming hypotensive, and the patient was then reassessed and an attempt to achieve haemostatic control with an angioplasty balloon was not successful.Patient was then brought to surgery to repair the arteriotomy.Patient was reported to be ok and surgery successful.
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 (943286).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.
Event or Problem Description
It was reported that physician used a 7f celt acd plus device to close an 8f arteriotomy after a 4-hour coronary cto procedure.The device was retracted to what was thought to be the arteriotomy after the distal wing was deployed.Upon raising to 90 degrees the blood signal did not completely stop so physician made multiple attempts to retract further and elevate again.The blood signal appeared to stop.Upon deployment of the proximal wing the device appeared to jump upward slightly.Implant was ejected, bleeding was noted and manual compression was used to achieve hemostasis for approximately 1 hour.The physician elected to give a blood transfusion since the patient was becoming hypotensive, and the patient was then reassessed and an attempt to achieve haemostatic control with an angioplasty balloon was not successful.Patient was then brought to surgery to repair the arteriotomy.Patient was reported to be ok and surgery successful.

• 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: 22068514
• Report Number: 3009984513-2025-00006
• Device Sequence Number: 8703205
• Product Code: MGB
• UDI-Device Identifier: 05391530280679
• UDI-Public: (01)05391530280679(17)271201(10)943286
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 06/12/2025

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-07
• Device Lot Number: 943286
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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; Hospitalization
• Patient Sex: Female